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.
Stuyvers Bread is recalling Pull-Apart Holiday Rolls due to possible metal contamination in a sub-ingredient. The affected product was distributed to select retailers in California, Connecticut, and Washington.
Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.
Impossible Foods is recalling Impossible Savory Ground Sausage nationwide due to potential metal contamination. Consumers should not consume affected products and should return them to their retailer.
Bakestone Brothers Pita Bread (6-count) is being recalled from five states due to metal fragments found in the product. Consumers should not consume the affected bread.
GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.
Aurobindo Pharma USA is recalling Nebivolol 2.5 mg tablets nationwide due to manufacturing deviations that resulted in the presence of N-Nitroso Nebivolol, a nitrosamine impurity, above acceptable intake limits.
Indianapolis Fruit Company is recalling 288 cases of cucumber products distributed to Indiana, Kentucky, Ohio, and Pennsylvania due to potential salmonella contamination.
L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps are being recalled due to potential metal contamination. Products were distributed in CT, KS, MN, OH, and TX.
Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.
Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.
A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.
Griffith Foods has recalled Item 79588401 (Italian Style Herb Powder) in 55 lb bags due to potential metal pieces. Affected lots 577773 and 577774 were distributed to IL, NY, NC, WI, TX, TN, and GA.
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.
GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.
GRIFFITH FOODS LTD has recalled 50-pound bags of Spicy Breading Export (LOT 575830) due to potential metal contamination. Affected product was distributed to IL, NY, NC, WI, TX, TN, and GA.
Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.
Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.
REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.
Yoder's Cashew Crunch Corn, unlabeled bulk candy coated popcorn, is being recalled because milk allergen is not declared. The product was distributed to retail and wholesale locations in Iowa and Georgia.
GRIFFITH FOODS LTD is recalling 25,903 pounds of Italian Meatball Dry Mix due to potential metal pieces in the product. The product was distributed across IL, NY, NC, WI, TX, TN, and GA.
CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.
Griffith Foods Ltd is recalling Item 25293502 Adhesion Breader EX due to potential pieces of metal in the product. The recall affects approximately 25,903 pounds distributed across multiple states.
Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.
CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.