A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.
Recall Database
Medical Device Defects Recalls
Every record in this hub — all 367 — is an FDA medical-device recall. These are the devices used in hospitals, clinics, and homes: infusion and delivery systems, catheters, implants, imaging and monitoring equipment, surgical instruments, and reprocessed single-use devices. A record lands here when the recall text points to a device malfunction, a design or manufacturing defect, a labeling error, or a sterility or packaging failure.
Almost all of these notices are recent — 366 of the 367 published in 2026. That reflects the current FDA ingestion window, not the full history of device recalls — read the scope note below before treating the count as a total.
Use this hub to look up a device by manufacturer or model. Every row links to the FDA enforcement record, which carries the recall classification and the firm's corrective action.
How this hub is built. This page groups the 367 recall records that 411 Press classifies as Medical Device Defects. Each record gets one primary hazard from a fixed, published rule set (taxonomy version 2026-07-28.C2.2 — this stamp marks when the classification rules last changed, not how current the recall data is; data currency is stated below). A record can carry secondary hazard tags but appears on only one hub. Regulators in this hub: FDA (367). These notices were published 2025–2026. This is not an all-time archive — it is the current dataset, drawn from CPSC, FDA, and NHTSA notices and refreshed as new notices are ingested from the agency feeds, so it grows over time. A note on counting. This hub counts RECORDS, not recall events. The agencies package recalls differently — NHTSA issues one record per safety campaign, the CPSC one per recall, the FDA one per affected product line — so an FDA-heavy hub carries more product-line records per underlying recall than a CPSC or NHTSA one. Records here are grouped by hazard; the brand hubs, which rank companies, count by event instead. Every row links to the original agency notice. The agency's record is the authority; the hazard grouping is ours. For a small number of records the agency feed's own hazard text did not pass our integrity check; those rows read "See the agency notice for the hazard description" and link straight to the source, rather than show a summary we can't stand behind.
2026 (366)
- FDAClass I
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- FDAClass I
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- FDAClass I
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
- FDAClass I
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
- FDAClass I
MEDLINE convenience kits labeled as: 1) C-SECTION
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
- FDAClass I
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
- FDAClass I
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
Arterial Line Kit 20ga x 6, REF: 400115A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- FDAClass I
Breathing circuit set
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
- FDAClass I
Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- FDAClass I
A M S, ALIGNED MEDICAL SOLUTIONS, Dr
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass I
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass I
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass I
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass I
Hillrom VOLARA System P.CIRCUIT 5KIT AC
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- FDAClass I
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit)
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- FDAClass I
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit)
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- FDAClass I
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit)
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- FDAClass I
Automated Impella Controller (AIC), for use with left heart support blood pump
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
- FDAClass I
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
- FDAClass I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- FDAClass I
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- FDAClass I
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: DRAINAGE KIT/AK-01600
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: ACCESS TRAY/GU-04020
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: ACCESS TRAY/ASK-04001-SUH-S
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: ACCESS TRAY/ASK-04001-MC3
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass I
Description/REF: ACCESS TRAY/ASK-04001-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- FDAClass II
Philips Upgrade to MR 7700 with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips MR 7700 with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia Elition X with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia Elition S with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia Ambition X with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia Ambition S with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia 3.0T CX with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia 3.0T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia 1.5T CX with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Ingenia 1.5T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Evolution upgrade 3.0T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Evolution Upgrade 1.5T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Achieva 3.0T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Achieva 1.5T Initial system with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
Philips Achieva 1.5T with MR Elastography (MRE)
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
- FDAClass II
LIFEPAK 15
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
- FDAClass II
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
- FDAClass II
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic Tip Steerable, Product Number 6DYNTP001
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass II
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- FDAClass I
NextStep Antegrade Chronic Hemodialysis Catheter
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- FDAClass I
Cannon II Plus Hemodialysis Catheter
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- FDAClass I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- FDAClass I
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- FDAClass II
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- FDAClass II
BD GasPak EZ CO2 Pouch System
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
- FDAClass II
BD GasPak EZ Campy Pouch System
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
- FDAClass II
LVIS Intraluminal Support Device
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass II
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- FDAClass I
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
- FDAClass II
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
- FDAClass II
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
- FDAClass II
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
- FDAClass II
Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass II
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
- FDAClass I
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- FDAClass I
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- FDAClass I
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- FDAClass II
i-STAT G3+ cartridge; List Number: 03P78-26
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- FDAClass II
i-STAT EG7+ cartridge; List Number: 03P76-25
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- FDAClass II
i-STAT EG6+ cartridge; List Number: 03P77-25
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- FDAClass II
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- FDAClass II
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- FDAClass II
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- FDAClass II
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
- FDAClass II
LUX-Dx II Plus
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- FDAClass II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- FDAClass I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
- FDAClass II
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
- FDAClass II
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- FDAClass II
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- FDAClass II
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Resorbable bone void filler falls outside standard specifications.
- FDAClass II
BioCera Fibers
Resorbable bone void filler falls outside standard specifications.
- FDAClass I
Rolls of label stock used with the Omnicell i.v.Station
Potential for mislabeled syringe produced by the i.v.STATION device.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
XXX
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass II
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
- FDAClass III
Heraeus, PALAMIX duo
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
- FDAClass III
Heraeus, PALAMIX uno
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
- FDAClass II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm
Potential for detachment of a distal tip component of the device during use.
- FDAClass II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm
Potential for detachment of a distal tip component of the device during use.
- FDAClass II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm
Potential for detachment of a distal tip component of the device during use.
- FDAClass II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm
Potential for detachment of a distal tip component of the device during use.
- FDAClass II
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
- FDAClass II
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
- FDAClass II
Prodisc C SK U.S
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
- FDAClass II
Prodisc C SK U.S
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
- FDAClass II
Brand Name: DONJOY Product Name: ICEMAN W/
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
- FDAClass II
Brand Name: DONJOY Product Name: ICEMAN W/
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
- FDAClass II
Brand Name: DONJOY Product Name: ICEMAN
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
- FDAClass II
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
- FDAClass I
Boston Scientific Pacemaker
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
- FDAClass I
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
- FDAClass I
B
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
B
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
B
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
B
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
B
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
- FDAClass I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
- FDAClass II
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- FDAClass II
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- FDAClass II
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- FDAClass II
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- FDAClass I
Medical Action Industries Inc
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
- FDAClass II
Flamingo Funnel Small, Model Number SQ20012-01
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- FDAClass II
Flamingo Funnel Medium, Model Number SQ20012-02
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- FDAClass II
Flamingo Funnel Large, Model Number SQ20012-03
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
- FDAClass II
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Centurion medical convenience kits
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Centurion medical convenience kits
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
Centurion medical convenience kits
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- FDAClass II
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
- FDAClass II
Access Total T4 Calibrator, Catalog No
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
- FDAClass II
LeadCare Ultra Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- FDAClass II
LeadCare¿ Plus Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- FDAClass II
(1)(2) LeadCare¿ II Blood Lead Test Kit
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- FDAClass I
Halyard VA DETROIT CATH LAB PACK kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard SAMMC ANGIOGRAPHY kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard PERC TRAY kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard NEURO IR PERIPHERAL (PS 64405) kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard HEART CATH, SELF REGIONAL kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard CATH LAB kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard CATH LAB kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard CARDIAC CATH TRAY SHANDS JAX kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard CARDIAC CATH PACK SAN23CARDQ kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Halyard CARDIAC CATH PACK kit
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass II
ARTIS Pheno VE30A and VE40A, Model 10849000
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- FDAClass I
Omnipod 5 Pods
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
- FDAClass II
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Product does not have FDA clearance.
- FDAClass II
iLet Bionic Pancreas, REF: BB1001
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
- FDAClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- FDAClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- FDAClass II
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
- FDAClass II
Medtronic Sphere-9 Catheter
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
- FDAClass II
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
FLEXTIP PLUS EPIDURAL CATHETER
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
ARROW
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- FDAClass II
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
- FDAClass II
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
There is a possibility of reagent leakage from the specimen container.
- FDAClass II
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
- FDAClass II
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number
Due to complaints of device breakage at the traction force gauge to handle joint.
- FDAClass II
Philips Spectral CT on Rails
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
- FDAClass II
COOK MEDICAL Arterial Pressure Monitoring Tray
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- FDAClass II
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft -Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
Soft-Vu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
AccuVu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
AccuVu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
AccuVu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass II
AccuVu Angiographic Catheter
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
- FDAClass I
NAMIC Angiographic Control Syringe, labeled as follows: 1
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Medline medical convenience kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass I
Medline medical convenience kits
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO
Unapproved design changes to the products outside of the 510(k) clearance.
- FDAClass II
Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) SYR CONTROL 8ML ROTATING
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) NEWBORN ADMISSION
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) ENT PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) CATH LAB CDS
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) ARTHROGRAM TRAY
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) ANGIOGRAPHY PACK-LF
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- FDAClass II
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- FDAClass II
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
- FDAClass II
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- FDAClass II
Diowave Laser System, REF: Diowave 250W
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
- FDAClass II
See RES for full list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See RES for complete list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See RES for complete list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See RES for complete list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See RES for complete list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See RES for complete list
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See full list in RES
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
See complete list in RES, exceeds character limit
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Surgical Packs: 1) PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Surgical Drapes: 1) SHEET
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) SCC RF PAIN MGMT
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) PICC LINE TRAY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) OB KIT
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) LITHOTOMY PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT UROLOGY SLING
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) HYSTEROSCOPY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) DRAPE PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) CVC PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) C-SECTION PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) ARTHROSCOPY CDS
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) ANCILLARY PACK-LF
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- FDAClass II
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
2025 (1)
- FDAClass II
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.