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.
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
The Quaker Oats Co. is recalling Quaker Chewy Bars Less Sugar Chocolate Chip due to potential Salmonella contamination. Affected products have a Best Before date of August 2, 2024, or earlier.
The Quaker Oats Co. is voluntarily recalling Crunchy & Chewy Snacks variety packs due to potential Salmonella contamination. The recall includes products with Best Before dates of August 2, 2024, or earlier.
The Quaker Oats Co. is recalling Quaker Chewy Dipps Peanut Butter bars due to potential Salmonella contamination. The recall affects products with a Best Before date of Aug-02-24 or earlier.
Quaker Big Chewy Bars Peanut Butter Chocolate Chip are recalled due to potential Salmonella. The Quaker Oats Co. initiated this voluntary recall in December 2023.
Frito-Lay has recalled Snack Time Favorites variety packs due to potential Salmonella contamination. Affected products have a Best Before date of August 2, 2024 or earlier and were distributed nationally and internationally.
Integra LifeSciences is recalling 161 units of the Cranial Access Kit (Lot 7124720) due to packaging defects that may compromise sterility. The recall affects units distributed worldwide.
The Quaker Oats Co. is recalling Quaker Chewy Bars Chocolate Chip in multiple sizes due to potential Salmonella contamination. The recall affects products distributed nationwide and internationally with a Best Before date of August 2, 2024, or earlier.
Denver Solutions is recalling Moxifloxacin PF eye injection vials nationwide due to glass delamination in the vials. The affected product is used for eye surgery injections.
Quaker Chewy Dipps Llama Rama snacks are being recalled nationally due to potential Salmonella contamination. Products with a Best Before date of Aug-02-24 or earlier are affected.
Medline Industries recalls 844 units of nursing education kits and trays due to potential lack of sterility in Nurse Assist irrigation solution components. Products distributed nationwide and internationally.
Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.
Mutti USA is recalling MUTTI Crushed Tomatoes because the internal can lining may be detaching into the product. The recall affects 137,634 units distributed to 24 states.
Equate Stye Lubricant Eye Ointment is being recalled due to lack of assurance of sterility. Approximately 355,633 units have been distributed nationwide and are affected.
United Orthopedic Corporation recalls USTAR II knee implants due to potential incorrect orientation of the curved stem. Affected products were distributed across multiple US states and internationally.
Quaker Chewy Granola Breakfast Cereal in chocolate flavor is recalled due to potential Salmonella contamination. Affected products have a 'Best Before' date of Aug-02-24 or earlier and were distributed nationally and internationally.
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
The Quaker Oats Co. is recalling Quaker Chocolatey Favorites Snack Mix (Best Before Aug-02-24 and earlier) due to potential Salmonella contamination. The product was distributed nationally across all US states, Puerto Rico, Guam, Saipan, and internationally.
Quaker Chewy Dipps Chocolate Chip bars are being recalled nationwide due to potential Salmonella contamination. Affected products have a Best Before date of Aug-02-24 or earlier.
The Quaker Oats Co. is recalling Quaker Simply Granola Oats, Honey, Raisins & Almonds Cereal due to potential Salmonella. Affected products have Best Before dates of August 2, 2024, or earlier and were distributed nationally and internationally.
The Quaker Oats Co. is voluntarily recalling Cap n Crunch Sea Berry Crunch Cereal 15.5 oz boxes due to potential Salmonella contamination. The recalled products have a Best Before date of Aug-02-24 or earlier.
The FDA is recalling Fluticasone Propionate Nasal Spray due to suspected potential presence of Burkholderia cepacia complex bacteria. The affected lot (TX5275) was distributed nationwide.
United Orthopedic Corporation is recalling the USTAR II Hip System Press-Fit Curved Stem due to a potential risk that the implant curved stem may be oriented incorrectly. The FDA Class II recall affects 598 units.
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.