Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
Favorite Day Bakery White Fudge Mini Cookies (7oz) recalled nationwide in the US and Canada due to potential salmonella contamination.
Black Forge Knives is recalling multiple kitchen knife models distributed in Georgia and via Bespoke Post due to elevated lead levels in the blades.
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.
Panaderia Guatemex is recalling Sheca Redonda bread due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
Premo Meat Lovers 7oz packages are being recalled due to potential Salmonella contamination. Affected products have a Best By Date of 7/13/24 and Lot Code 25202406.
Panaderia Guatemex is recalling Conchas Guatemala pastry products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.
Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.
A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.
A software issue in BD PYXIS automated dispensing cabinets may cause incorrect medication bin labels to print during restocking, potentially leading to medication dispensing errors. CareFusion is recalling 16 units.
CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.
CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.
BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.
Panaderia Guatemex is recalling 170 bags of Roscas due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.
Siemens LUMINOS Lotus Max X-ray displays are being recalled because the support arm may lower unintentionally, potentially injuring people nearby during positioning.
Olympus is recalling Everest Bipolar Cutting Forceps surgical instruments due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. Affected batches: FR150448, FR154445, FR173022.
GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.
Panaderia Guatemex is recalling Sheca Anis bread products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.