Medical Device Defects Recalls

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.

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.

Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2.

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.

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

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.

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model

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.

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.

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.

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.

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.

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.

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF):

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.

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF):

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.

Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.

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.

Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF):

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.

Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number

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.

Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number

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.

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

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.

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

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.

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

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.

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.

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3

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).

Medtronic Marinr Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable

Incomplete seals on sterile product

Daig Livewire Steerable BDB

Incomplete seals on sterile product

CS Uni-Directional w Auto ID

Incomplete seals on sterile product

CS Uni-Directional w Auto ID

Incomplete seals on sterile product

BW Webster Duo-Decapolar

Incomplete seals on sterile product

BARD EP XT Steerable

Incomplete seals on sterile product

BARD EP XT Decapolar Steerable

Incomplete seals on sterile product

BARD Dynamic XT Steerable

Incomplete seals on sterile product

BARD Dynamic XT Steerable

Incomplete seals on sterile product

BARD Dynamic XT Deca Steerable

Incomplete seals on sterile product

BARD Dynamic Tip Steerable

Incomplete seals on sterile product

BARD Dynamic Tip Steerable

Incomplete seals on sterile product

BARD Dynamic Tip Steerable

Incomplete seals on sterile product

BARD Dynamic Deca Steerable

Incomplete seals on sterile product

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Philips Bridge Prep Kit REF: K12-09098C Sterile EO

catheter may experience resistance when being advanced over the guidewire

Philips Bridge Prep Kit REF: K12-09098C Sterile EO

catheter may experience resistance when being advanced over the guidewire

Philips Bridge Prep Kit REF: K12-09098B Sterile EO

catheter may experience resistance when being advanced over the guidewire

Uric Acid in vitro diagnostic test REF: 31H0P

The devices were distributed without required FDA premarket clearance or approval.

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

The devices were distributed without required FDA premarket clearance or approval.

One Step UTI in vitro diagnostic test REF: 3374

The devices were distributed without required FDA premarket clearance or approval.

One Step pH in vitro diagnostic test REF: 31I4P

The devices were distributed without required FDA premarket clearance or approval.

One Step P in vitro diagnostic test REF: 8194

The devices were distributed without required FDA premarket clearance or approval.

One Step K in vitro diagnostic test REF: 81A4

The devices were distributed without required FDA premarket clearance or approval.

One Step 10A in vitro diagnostic test

The devices were distributed without required FDA premarket clearance or approval.

i-STAT G3+ cartridge

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.

i-STAT EG7+ cartridge

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.

i-STAT EG6+ cartridge

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.

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.

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.

ERBEFLO 2

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.

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.

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.

LUX-DX II

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.

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.

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

ZENBONE

Resorbable bone void filler falls outside standard specifications.

BioCera Fibers

Resorbable bone void filler falls outside standard specifications.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

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OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

OER-ELITE Endoscope Reprocessor Connecting Tubes.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

DEX Ophthalmic Tissue Forceps

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.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

DEX Ophthalmic Tissue Forceps

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm.

Potential for detachment of a distal tip component of the device during use.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm.

Potential for detachment of a distal tip component of the device during use.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm.

Potential for detachment of a distal tip component of the device during use.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm.

Potential for detachment of a distal tip component of the device during use.

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog

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.

Gentuity HF-OCT Imaging System Model G10-01

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.

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

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.

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

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.

Brand Name: DONJOY Product Name: ICEMAN W/

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Brand Name: DONJOY Product Name: ICEMAN W/

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Brand Name: DONJOY Product Name: ICEMAN

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

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.

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator

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.

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator

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.

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator

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.

Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator

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.

Flamingo Funnel Small

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Flamingo Funnel Medium

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Flamingo Funnel Large

Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

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.

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.

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.

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.

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.

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.

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.

CENTURION Circumcision Kit

On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.

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.

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.

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.

(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.

ARTIS Pheno VE30A and VE40A

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.

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

Product does not have FDA clearance.

Custom Convenience Kits Pre Op Kit - NS

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).

Custom Convenience Kits Pre Op Kit - NS

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).

Custom Convenience Kits Pre Op Kit - NS

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).

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.

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

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code:

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code:

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

FLEXTIP PLUS EPIDURAL CATHETER

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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

ARROW

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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

LSL Healthcare Wound Closure Tray

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

LSL Healthcare

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

LSL Healthcare

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

LSL Healthcare

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

LSL Healthcare

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

LSL Healthcare

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

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.

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.

COOK MEDICAL Arterial Pressure Monitoring Tray

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B

Unapproved design changes to the products outside of the 510(k) clearance.

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.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK

Unapproved design changes to the products outside of the 510(k) clearance.

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.

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.

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.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF

Unapproved design changes to the products outside of the 510(k) clearance.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126

Unapproved design changes to the products outside of the 510(k) clearance.

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.

Medline Namic Syringes: 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.

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.

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.

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.

Medline Kits: 1) PICC TRAY

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) NEWBORN ADMISSION

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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.

Medline Kits: 1) LABOR PACK-22025208-LF

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) HYSTEROSCOPY PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) HEART TRANSPLANT BIOPSY

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) GYN LAPAROSCOPY PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) GENERAL LAPAROSCOPY

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ENT PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) D AND C PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) CATH LAB CDS

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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.

Medline Kits: 1) BREAST PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ARTHROSCOPY PACK

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ARTHROGRAM TRAY

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ANGIOGRAPHY PACK-LF

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

React Health PHOENIX 5L Oxygen Concentrator

Devices which did not meet internal quality specifications were inadvertently distributed.

On-X Mitral Heart Valve with Conform-X Sewing Ring

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Diowave Laser System

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Medline Convenience Kits: 1) WMC I D 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.

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.

Medline Convenience Kits: 1) PPE 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.

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.

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.

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.

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.

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.

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.

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.

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION

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.

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.

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.

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.

Medline Convenience Kits: 1) KIT GENERAL CLOSURE

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.

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.

Medline Convenience Kits: 1) DYNDA3003

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.

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.

Medline Convenience Kits: 1) DRAPE PACK-CHOICE

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.

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.

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.

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.

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.

Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN

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.

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.

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.

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.

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.

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.

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.

Medline Convenience Kits: 1) ADMIT 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.

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.