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.
Chetak New York is recalling Deep-brand frozen punjabi tinda after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen singoda water chestnuts after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Hudson River Foods is recalling 113 units of Doughy brand Chocolate Chip Cookie Dough because the product may be contaminated with Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen surti papdi lilva after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen fansi cut French beans after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Moonlight Packing is recalling 439 bags of 4-count Peppermint Peach packs over potential contamination with Listeria monocytogenes. The FDA has classified the action as Class I.
Draeger is recalling 14,420 ErgoStar CM 40 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen karela ring cut after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Draeger is recalling 191,470 ErgoStar CM 45 airway connectors after multiple complaints in which cracks formed in the hose of specific catheter mounts. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen tindora after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen red guava slices after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen chauri after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Medline is recalling 163 DEXLOCK Achilles Repair Implant Kits after multiple complaints of the drill bit fusing to the bushing within the drill guide during use.
Steris is recalling 22 AMSCO 7053HP Washer/Disinfectors because a wire connected to the electrical box may shift out of position, which may result in electrical arcing inside the unit.
Orthofix U.S. is recalling 34,582 FORZA PTC Spacer System units because the labeling contains claims that are not consistently present.
Glenmark Pharmaceuticals is recalling 672 bottles of Nebivolol Tablets, 20 mg, over cross contamination with other products.
Medline is recalling 11,291,800 Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", because packaging may exhibit open seals that could compromise the sterility of the product.
Waldemar Link is recalling 18 Endo Model Knee Fusion Nail SK coupling components delivered with a preassembled locking screw inserted from the wrong side into the male taper.
Cipla USA is recalling 15,744 bottles of Cinacalcet Hydrochloride Tablets, 60 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.
Cipla USA is recalling Lanthanum Carbonate chewable tablets, 1000mg, after the product failed stability specifications with an out of specification hardness test result.
Medline is recalling 18,000 units of Curad Quick Strip Fabric Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Medline is recalling 1,566,500 Fur Friends Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.
Bard Peripheral Vascular is recalling 1,240 Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator can show the catheter in the sharp position when it is blunt.
Cipla USA is recalling 63,504 bottles of Cinacalcet Hydrochloride Tablets, 30 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.
Medline is recalling 4,381,400 Quick Strip Plastic Sterile Adhesive Bandages because packaging may exhibit open seals that could compromise the sterility of the product.