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.
Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).
GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.
Trader Joe's Solid Light Yellowfin Tuna is being recalled because the easy-pull lid may not be properly secured, potentially allowing botulism contamination. Approximately 14,147 cases nationwide are affected.
ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.
ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.
Aesculap Inc is recalling 93,714 hemostatic forceps across 83 models due to clamp breakage that occurs when forceps are used in ways not covered by the design.
Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.
Aspen Biopharma Labs is voluntarily recalling Voriconazole, an antifungal medication, due to manufacturing process deviations. The product was distributed to three distributors in Hong Kong and Florida.
Coyote Valley Sour Cream & Onion Chips from Uncle Rays, LLC are being recalled because the product contains more sodium than the label states. Affected products were distributed to customers in Ohio, Nevada, and Texas.
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.
Kids by babyganics SPF 50 sunscreen is being recalled due to chemical contamination. Approximately 449,502 units distributed nationwide in the U.S. and Canada are affected in this FDA Class II recall.
Black dried beans have been recalled due to elevated levels of fungicide residue. The affected product was distributed to Arizona, California, Idaho, and Oregon.
Kowa Pharmaceuticals America is recalling LIVALO (pitavastatin calcium) 4 mg tablets from a specific batch due to the presence of foreign tablets or capsules mixed with the correct medication. No illnesses have been reported.
San Miguel Nuts Corp. is recalling Mi More Coco Bandera snacks because the product label fails to declare a color ingredient. The recall affects 3,026 bars distributed to New Jersey.
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
JFE Franchising is recalling watermelon and cucumber products with Tajin seasoning due to potential Salmonella contamination. Affected packages were distributed in TX, LA, WY, and AZ with sell-by dates from October 12 through December 5, 2024.
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
JFE Franchising Inc is recalling approximately 1,950 packages of 11 oz Chef Salad due to potential Salmonella contamination. The affected products were distributed in Texas, Louisiana, Wyoming, and Arizona with sell-by dates from October 12, 2024, through December 5, 2024.
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
JFE Franchising is recalling garden salad products due to potential Salmonella contamination. Products were distributed in Texas, Louisiana, Wyoming, and Arizona.
Amazon Fresh Bake at Home Jumbo Sugar Cookie dough is being recalled due to undeclared egg. Consumers with egg allergies should not consume this product.
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
JFE FRANCHISING INC is recalling Cobb Salad products (22 oz and 11 oz packages) due to potential Salmonella contamination. Products were distributed in Texas, Louisiana, Wyoming, and Arizona.