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.
Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.
CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.
Yoder's Cashew Crunch candy coated popcorn is recalled due to undeclared milk allergen on package labels. 319 packages were distributed to retail and wholesale locations in Iowa and Georgia.
Yoder's Cashew Crunch hard candy is being recalled for undeclared milk allergen. The product was distributed in Iowa and Georgia to retail and wholesale customers.
Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.
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.
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.
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
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.
Griffith Foods Ltd recalls bulk food ingredient Item 16354301 due to potential metal contamination. Product was distributed to food service facilities in Illinois, New York, North Carolina, Wisconsin, Texas, Tennessee, and Georgia.
Stuyvers Bread is recalling Artisan Multigrain Baguettes (Lot #24313) due to possible metal contamination in a sub-ingredient. The product was distributed to two consignees in California, Connecticut, and Washington.
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.
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 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.
Ocean Group Inc. is recalling multiple frozen salmon products sold in California due to potential Listeria monocytogenes contamination detected in environmental samples at the production facility.
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.
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.
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.
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.
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.
Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.
Yoder's Cashew Crunch hard candy is being recalled due to undeclared milk allergen on the label. The product was distributed to retail and wholesale locations in Iowa and Georgia.
Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.
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.