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.
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
Snapchill, LLC is recalling Square One Coffee Roasters Berry Mint Tea with Honey canned beverages due to potential under-processing. The affected cans were distributed nationwide and in Canada.
Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.
The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.
Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.
Snapchill, LLC is recalling 549,146 cans of Coffee Hound and White Rhino coffee beverages for potential under-processing. Affected cans with expiration dates June 16, 2024–April 16, 2025 were distributed nationwide and in Canada.
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.
B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in adverse drug reactions or medication loss.
B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.
Snapchill, LLC is recalling approximately 549,146 cans of Coffee Hound and Helm brand maple latte beverages due to potential under-processing during manufacturing.
Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.
Snapchill, LLC is recalling Mud LLC Maple Mud canned black coffee with maple syrup beverages (12 oz, UPC 854555007058) nationwide and in Canada due to potential under-processing. Affected products have expiration dates from June 16, 2024 to April 16, 2025.
Zydus Pharmaceuticals recalls 432,250 vials of Cyanocobalamin Injection USP due to glass particulate matter. Affected vials are distributed in Tennessee.
B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.
Wehah Farms is recalling Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object of apparent rodent origin. Consumers should not consume the recalled product.
Greiner Bio-One is recalling VACUETTE blood collection tubes due to missing additive affecting clotting and separation. Defective tubes could delay patient treatment if samples require recollection.
B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.
Snapchill, LLC is recalling approximately 549,146 cans of coffee beverages with expiration dates between June 16, 2024 and April 16, 2025 due to potential under-processing. The affected beverages were distributed nationwide and in Canada.
Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.
Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.
Sands Impex Inc. recalled Asli Sesame Seeds Brown because a product sample exceeded the FDA tolerance level for the pesticide Fenvalerate. Affected consumers should not consume the product.
Snapchill, LLC is recalling Emergency Medical Coffee Sweet Cream canned beverages due to potential under-processing. The recall affects 549,146 cans with expiration dates June 16, 2024–April 16, 2025, distributed nationwide in the US and Canada.
Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers, with no reported illnesses or injuries.
StellaLife VEGA Oral Care Peppermint rinse is recalled nationwide due to microbial contamination with Terribacillus species. The affected product was distributed to 60 physician offices.
Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.