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.
C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 6 Fr x 30 cm, because the actual stent size may not match the product label.
Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.
Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels because certain lots may have a small protrusion or hair-like deformity that can cause instrument errors and delay patient results.
Chetak New York is recalling Deep-brand frozen surti undhiu mix after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Stryker is recalling 294 MV3 bariatric beds because they and Arise 1000EX mattresses have been sold in close proximity, and the two products have not been tested for compatibility.
Orthofix U.S. is recalling 40,956 CONSTRUX Mini Ti Spacer System units because the labeling contains claims that are not consistently present.
C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 8 Fr x 26 cm, because the actual stent size may not match the product label.
Lupin Pharmaceuticals is recalling 52,128 bottles of Sertraline Hydrochloride Tablets, 100 mg, over a defective container in which the seal is not adhering to the bottles.
C.R. Bard is recalling 116 Bard InLay Optima Ureteral Stent Kits, 6 Fr x 14 cm, because the actual stent size may not match the product label.
C.R. Bard is recalling 4,350 BD InLay Optima Ureteral Stent Kits, 4.7 Fr x 26 cm, because the actual stent size may not match the product label.
Stryker is recalling 297 Arise 1000EX mattresses because they and certain MV3 beds have been sold in close proximity, and the two products have not been tested for compatibility.
Winder Laboratories is recalling 3,528 bottles of Morphine Sulfate Oral Solution because the size stated on the carton label did not match the size of the bottle inside.
Orthofix U.S. is recalling 61,977 CONSTRUX Mini PTC Spacer System units because the labeling contains claims that are not consistently present.
Orthofix U.S. is recalling 14,201 Forza Ti Spacer System units because the labeling contains claims that are not consistently present.
Steris is recalling 10 AMSCO 7052HP Washer/Disinfectors because a wire connected to the electrical box may shift out of position, which may result in electrical arcing inside the unit.
Chetak New York is recalling Deep-brand frozen mixed vegetables after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Datascope is recalling 11,470 Cardiosave Hybrid Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.
GE Medical Systems is recalling 1,818 Senographe Pristina mammography systems because some have a missing or incorrect X-Ray Warning label.
Chetak New York is recalling Deep-brand frozen suran after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Datascope is recalling 47 Cardiosave Rescue Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.
Chetak New York is recalling Deep-brand frozen baby bhindi after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Africa Imports is recalling Organic Moringa Leaf Powder from lot SO-71449 after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Genepro Protein is recalling 250 bags of Genepro Whey 4th Generation protein because the labeling contains incorrect ingredient information and fails to declare milk as an allergen.
Alanwar Food Corp is recalling Sonex brand aluminum pots after the products were found to contain leachable lead levels of 0.323mg/L. The FDA has classified the action as Class I.
Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.