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.
AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.
Philips Zenition 50 imaging systems may experience mains control unit fuse failure during startup or procedures. The defect could cause equipment malfunction.
MEERA CL mobile operating tables may experience an error code that causes the table to stop moving unexpectedly during surgery, resulting in procedural delays.
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.
Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.
Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.
Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.
Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.
Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.
Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.
Berkeley Club Beverages is recalling Berkeley Springs Water Purified and Distilled due to coliform contamination detected during testing. The recall affects 1,304 bottles distributed in West Virginia, Maryland, and Virginia.
Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse Whole Grain White Hot Dog Buns for containing undeclared sesame. Approximately 10,987 cases distributed across multiple states.
Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.
Perfection Bakeries is recalling Aunt Millie's Bakehouse Texas Toast due to undeclared sesame, which poses a serious risk to consumers with sesame allergies. Approximately 1,500 cases were distributed across multiple states.
Perfection Bakeries recalls Aunt Millie's Bakehouse White Pullman Bread (22 oz) due to undeclared sesame. The recall affects 7,092 cases distributed across multiple states.
Aunt Millie's Bakehouse Hawaiian Hamburger Buns contain undeclared sesame and are being recalled by Perfection Bakeries LLC. The Class I recall affects 6,400 cases distributed across 12 states.
Perfection Bakeries is recalling Gordon Food Service Hawaiian Pull-Apart Dinner Rolls due to undeclared sesame. The recall affects 61,658 cases distributed across 12 states; consumers with sesame allergies should not consume the product.
Perfection Bakeries LLC is recalling 1,144 cases of Aunt Millie's Bakehouse Whole Grain Dinner Rolls due to undeclared sesame. The product was distributed in 12 states. Consumers with sesame allergies should not consume this product.
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse 100% Whole Wheat Pullman Bread due to undeclared sesame. Affected product was distributed across twelve U.S. states.
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.
My Chai Inc is recalling MyChai Chai Tea Concentrate KALI nationwide because pH levels were found above 4.1 and production records are missing. Consumers should not consume the product.
Kirkland Signature Unsalted Sweet Cream Butter is being recalled because the label lists cream as an ingredient but is missing the required 'Contains Milk' allergen statement. Consumers with milk allergies should not consume this product.
Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.