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.
MAMTAKIM Inc. is recalling ground cinnamon products distributed to nine states due to elevated lead content. The 15 g paper carton product carries code 10C035.
Reser's Fine Foods is recalling 182 cases of Potatoes Creamy Deluxe Special Request due to temperature abuse that may cause food spoilage.
SSP America PHX, LLC is recalling Cheese Danish pastries distributed in Arizona. The product labels list cheese but fail to declare milk in the allergen statement, posing a risk to consumers with milk allergies.
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.
Reser's Fine Foods is recalling 7 cases of Smokehouse Potato Salad due to potential spoilage from temperature abuse during shipping. No illnesses have been reported.
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials distributed nationwide.
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
Reser's Fine Foods recalls 6 cases of Item 71117.03034 Banana Pudding Kit due to temperature abuse from a malfunctioning refrigeration unit. Affected products were distributed to CA, IL, MN, ND, and SD.
W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.
Multiple apple juice brands sold nationwide are being recalled due to inorganic arsenic levels above FDA action thresholds. The recall affects approximately 141,298 cases sold by Refresco Beverages US Inc.
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
SSP America PHX is recalling Apple Danish products due to incorrect ingredient labeling. The label lists Almond Croissant ingredients instead of Apple Danish, creating a risk for consumers with tree nut allergies.
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
A software bug in BD Pyxis QFill medication cabinet systems may print incorrect medication bin labels during restocking, potentially causing medication errors. Three units are affected.
Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.
Beckman Coulter is recalling 17 DxI 9000 Access Immunoassay Analyzers due to cracks in the Internal Wash Buffer Tank that can cause leaking, potentially delaying test results and exposing users to chemical and physical hazards.
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
Reser's Fine Foods is recalling Reser's American Classics Scalloped Potatoes because a refrigeration unit malfunction caused temperature abuse during shipment, potentially leading to spoilage. Consumers should not consume this product.
Reser's recalls 104 cases of sweet corn with butter due to shipment temperature abuse that may cause spoilage. Use By date Sept. 9, 2024; distributed in CA, IL, MN, ND, and SD.
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.
Reser's American Classics Macaroni & Cheese (12 oz) is recalled because a malfunctioning refrigeration unit caused temperature abuse during shipment, which may cause spoilage.