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.
FGF LLC is recalling egg-shaped donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed in the US and Canada.
FGF, LLC is recalling dual-filled chocolate and Bavarian yeast ring donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed in the US and Canada.
Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
FGF, LLC is recalling over 2 million cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.
PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.
FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.
Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.
Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.
GBC Food Services (Yummi Sushi) has recalled multiple sushi roll products due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.
Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.
Frito Lay Inc. is recalling 6,344 bags of 13 oz. Lay's Classic Potato Chips distributed in Washington and Oregon due to an undeclared milk allergen that could cause allergic reactions.
GBC Food Services' Vegetable Bowl is being recalled due to potential Salmonella contamination. Products purchased in Colorado between November 22–29, 2024 may be affected.
Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.
Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.
Yummi Sushi has recalled multiple shrimp-based sushi roll products distributed in Texas due to possible Salmonella contamination. Consumers should not consume these products and should return them to the point of purchase.
Vegetable Ranch Tray products from Yummi Sushi may contain Salmonella. Consumers who purchased items between November 22-29, 2024 should not eat them and should discard or return them.
GBC Food Services (Yummi Sushi) is recalling 6,088 units of Individual Garden Salad due to potential Salmonella. Products purchased November 22-29, 2024, in Colorado are affected.
Corfu and Mediterranean brand tzatziki sauce in half-gallon tubs and 5-gallon pails are being recalled for potential Salmonella contamination. Consumers should not eat the affected products.
GBC Food Services is recalling Individual Greek Salads with purchase dates between November 22-29, 2024, due to potential Salmonella contamination. The recall affects 6,088 units distributed in Colorado.
GBC Food Services is recalling 6,088 units of Cucumber Slices W/Tajin (10 oz, UPC 850053685699) due to potential Salmonella contamination. Products purchased November 22-29, 2024, distributed in Colorado are affected.
GBC Food Services recalls a Large Vegetable Tray due to potential Salmonella contamination. Consumers who purchased this product between November 22-29, 2024, should not consume it.
Simple Truth Organic Broccoli Florets have been recalled due to potential contamination with Listeria monocytogenes. The affected product is a 12oz steam-in-bag broccoli from Mexico with a best-if-used-by date of November 8, 2024.
GBC Food Services, LLC (dba Yummi Sushi) is recalling Family Cobb Salad due to potential Salmonella contamination. The affected product was distributed in Colorado.