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.
Fat Choy Kee Dried Longan produced by HY SUCCESS INC. is being recalled because it contains undeclared sulfites. Sulfites are a known allergen that poses health risks to sensitive individuals.
Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.
The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).
Rizo Lopez Foods has recalled multiple sour cream and cream products due to Listeria monocytogenes contamination. Products were distributed across multiple U.S. states.
Tio Francisco Yogurt products in multiple flavors are being recalled due to potential Listeria monocytogenes contamination. Consumers who have purchased these yogurts should not consume them.
EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.
Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.
Rizo Lopez Foods is recalling Tio Francisco Queso Seco 14 oz. cheese due to Listeria monocytogenes contamination. The product was distributed across multiple U.S. states with production dates through July 31, 2024.
Denver Solutions is recalling 12,564 bags of PHENYLephrine HCl IV solution nationwide due to a semi-automated filling system malfunction that could dispense double doses to patients.
Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Rizo Lopez Foods recalled Oaxaca cheese products sold under multiple brand names due to potential Listeria monocytogenes contamination. The recall affects products distributed across multiple U.S. states.
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
Rizo Lopez Foods, Inc. is recalling various queso fresco products from multiple brands due to potential Listeria monocytogenes contamination. The affected products were distributed to retail locations in multiple U.S. states.
Tio Francisco Queso Para Freir (frying cheese) is being recalled due to potential Listeria monocytogenes contamination. The recall affects multiple batches distributed across multiple U.S. states.
Multiple ricotta cheese products from Rizo Lopez Foods are recalled nationwide due to potential Listeria monocytogenes contamination. Affected batches have best-by dates through April 2, 2024.
Bulk Monterey Jack cheese from Rizo Lopez Foods is being recalled due to Listeria monocytogenes contamination. The product was distributed to multiple U.S. states.
Ocean Group Inc. is recalling tuna products distributed in California due to potential Listeria monocytogenes contamination identified through FDA environmental sampling.
Ocean Group Inc. is recalling frozen salmon fillet products distributed in California due to potential Listeria monocytogenes contamination detected during FDA environmental sampling.
Melissa's Hot Kimchi Pickled Napa Cabbage is being recalled due to undeclared fish allergen. 124 cases were distributed to California, Texas, and Florida.
Rizo Lopez Foods is recalling Tio Francisco Blanco Suave cheese due to potential Listeria monocytogenes contamination. Affected products have date codes through March 23, 2024.