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.
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.
The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.
Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.
Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.
ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.
Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.
Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.
Target's Good & Gather Organic Jasmine Rice is being recalled due to rice weevils found in bags. Consumers should not consume affected product.
Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.
Dr. Berne's MSM DROPS 5% Solution is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects 3833 bottles distributed nationwide and internationally.
Amerisource Health Services LLC is recalling HydrALAZINE Hydrochloride Tablets, 10 mg, nationwide due to impurities exceeding specifications in a repackaged product batch.
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
Ice Cream House Strawberry Shortcake Roll products may contain Listeria monocytogenes. Consumers in Ohio, New Jersey, and New York should not consume affected products.
Ice Cream House is recalling round cakes (UPC 0-91404-15181-8) distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
ICE CREAM HOUSE is recalling 9-inch ice cream pies distributed in Ohio, New Jersey, and New York due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Ice Cream House is recalling Cup Cake Party products due to potential Listeria monocytogenes contamination. Products were distributed in Ohio, New Jersey, and New York.
Knickerbocker Homestyle hamburger buns are recalled due to undeclared milk, posing risk to consumers with dairy allergies. The voluntary recall affects 668 retail units distributed to stores and restaurants in southeastern Michigan.
Heart cakes from Ice Cream House are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.
Weis Quality Brownie Moose Tracks Ice Cream (48oz) is recalled due to undeclared egg. The product was distributed to retail locations in Delaware, Maryland, New Jersey, New York, Pennsylvania, Virginia, and West Virginia.
Ice Cream House is recalling Trimocha Vanilla ice cream due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, New Jersey, and New York.
ICE CREAM HOUSE is recalling Sorbet Swirl ice cream due to potential Listeria monocytogenes contamination. Affected products were distributed in Ohio, New Jersey, and New York.
Ice Cream House is recalling Dessert on Wheels products sold in Ohio, New Jersey, and New York because they may be contaminated with Listeria monocytogenes. Consumers should not consume the affected products.