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.
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in the sterile packaging that may compromise product sterility. Affects 30 units distributed worldwide.
The Quaker Oats Co. is recalling Frito-Lay Popped & Baked Chips variety packs for potential Salmonella contamination. Affected products have best-before dates of August 2, 2024 or earlier and were distributed nationally and internationally.
Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.
Chin Jung White Kimchi is being recalled because it contains undeclared fish, a common allergen. Consumers with fish allergies should not consume this product.
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.
Integra LifeSciences is recalling the INS7280 Cranial Access Kit due to a packaging defect that may compromise product sterility. The recall affects 82 units distributed worldwide.
The Quaker Oats Company is recalling Quaker Chewy Bars Oatmeal Raisin due to potential Salmonella contamination. The recall affects approximately 22.5 million cases distributed nationally and internationally.
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure under vibration, temperature changes, or shock.
The FDA is recalling USTAR II Knee System implants due to potential incorrect orientation of the curved stem. The defect may affect proper implant positioning in knee replacement surgery.
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.
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 Rebstock Holding rod for fixation, a surgical instrument, may move or twist uncontrollably during use, potentially compromising patient safety if the movement transfers to attached equipment.
Quaker Oats is recalling Quaker Chewy Bars Less Sugar variety across multiple package sizes due to potential Salmonella contamination. The recall affects products distributed nationally and internationally with Best Before dates of August 2, 2024 or earlier.
The Quaker Oats Co. is recalling Gamesa Marias Cereal due to potential Salmonella contamination. The recall affects products distributed nationwide and internationally with a Best Before date of Aug-02-24 or earlier.
Integra LifeSciences is recalling 27 units of its Cranial Access Kit due to defective sterile packaging that may compromise product sterility. The kits were distributed worldwide.
The Quaker Oats Company recalled Cap'n Crunch Treats Peanut Butter Crunch Cereal Bars due to potential Salmonella contamination. Affected products have a Best Before date of August 2, 2024 or earlier.
The Quaker Oats Co. is recalling Cap n Crunch OOPS! All Berries Cereal (10.3 oz) due to potential Salmonella contamination. Products with a Best Before date of Aug-02-24 or earlier are affected nationally.
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. recalls Lunch Box Mix Frito-Lay Chips, Cookies and Quaker Chewy Bars Variety Pack (40ct, 40.62 oz) due to potential Salmonella contamination. The product was distributed nationally and internationally.
Reser's Amish Macaroni Salad is recalled because some containers have a mislabeled side label that does not declare wheat, which is an ingredient in the product. This poses a risk to people with wheat allergies.
The Quaker Oats Company is voluntarily recalling Quaker Chewy Dipps Variety Pack snack bars due to potential Salmonella contamination. The recall affects products distributed nationally across all U.S. states, territories, and some international markets.
Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.
The Quaker Oats Co. is recalling Quaker Chewy Bars Peanut Butter Chocolate Chip due to potential Salmonella contamination. Affected products were distributed nationally and internationally with best-before dates of August 2, 2024 or earlier.
The Quaker Oats Co. is recalling Quaker Chewy Bars Chocolate Chip Spring Minis nationwide due to potential Salmonella contamination. Affected products have a Best Before date of August 2, 2024, or earlier.
Alphatec Spine recalls IdentiTi ALIF graft bolts after reports of breakage during implantation. Approximately 12,777 devices are affected worldwide.