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.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.
M&P Food Productions is recalling Potato & Mushroom Vareniki because the products contain undeclared wheat, which poses a risk to consumers with wheat allergies.
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
Skagit River Bakery & Cafe is recalling marionberry scones distributed in Washington due to undeclared soy lecithin and soybean oil on labels. Consumers with soy allergies should not consume this product.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
M & P Food Productions is recalling Sour Cherry Vareniki frozen dumplings due to undeclared wheat, a major allergen not listed on the label.
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.
Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.
GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.
M&P Food Productions is recalling Farmer Cheese Vareniki due to undeclared wheat and milk allergens. The frozen product was distributed across seven states from August 2023 to August 2024.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
M&P Food Productions recalls frozen Pirozhki pies distributed across multiple states due to undeclared wheat and milk in the product. Consumers with wheat or milk allergies should not consume these products.
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
M&P Delicacies frozen pirozhki pies contain undeclared wheat and milk allergens. Consumers with allergies to these ingredients should not consume the product.
Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.