Warning
Class II
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems
FDA Recalls
Page 19 of 39 · 1,907 total recalls
Recalls — Page 19
Warning
Class II
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
Merit Medical Systems
Critical
Class I
RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204001160
Multi-state outbreak of E. coli O157:H7.
Raw Farm LLC
Critical
Class I
RAW FARM RAW CHEDDAR Jalapeno NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP
Multi-state outbreak of E. coli O157:H7.
Raw Farm LLC
Critical
Class I
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP
Multi-state outbreak of E. coli O157:H7.
Raw Farm LLC
Critical
Class I
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE
Multi-state outbreak of E. coli O157:H7.
Raw Farm LLC
Critical
Class I
RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194
Multi-state outbreak of E. coli O157:H7.
Raw Farm LLC
Warning
Class II
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and...
Siemens Healthcare Diagnostics Inc
Critical
Class I
Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen,
Wawa Beverage Company
Critical
Critical
Critical
Critical
Class 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...
Windstone Medical Packaging
Warning
Class 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...
Abbott Point Of Care Inc.
Warning
Class 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...
Abbott Point Of Care Inc.
Warning
Class 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...
Abbott Point Of Care Inc.
Warning
Class II
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October...
Aniara Diagnostica LLC
Warning
Class II
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
BioFire Diagnostics
Warning
Warning
Class II
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So
Lack of Assurance of Sterility
International Medication Systems Ltd.
Warning
Class II
Label is predominantly green with white lettering in a clear plastic clamshell container
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
PURE PALM C/O DVD
Warning
Class II
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Class II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Class II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Warning
Class II
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Class 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...
Erbe Medical
Warning
Class 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...
Erbe Medical
Warning
Class 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...
Erbe Medical
Warning
Class II
Philips Azurion
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling...
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Warning
Class 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...
Boston Scientific Corporation
Warning
Class 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...
Boston Scientific Corporation
Warning
Class 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...
Zimmer
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count
Contains undeclared egg, soy, and hazelnut
Blueroot Health
Warning
Class 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.
Edwards Lifesciences
Warning
Class 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.
Micro-X Ltd.
Critical
Class 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...
North American Rescue LLC.
Warning
Class II
Straumann n!ce PMMA Full-arch Restoration
Includes an incorrect screw seat interface.
Straumann USA LLC
Warning
Class II
Straumann n!ce Zr, HT, Full-arch Restoration
Includes an incorrect screw seat interface.
Straumann USA LLC
Warning
Class II
Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
Product may contain foreign objects, specifically glass.
FINESALER LLC
Warning
Class II
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems