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.
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Ben E Keith Foods has recalled 1721 cases of frozen and refrigerated foods that were temperature abused during storage and transit. The temperature-compromised products were distributed to food service operations.
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Ben E Keith Foods is recalling approximately 1,721 cases of multiple frozen vegetable and side-dish products due to temperature abuse during shipment. Consumers should discard affected products.
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Ben E Keith Foods is recalling Greek Feta dressing and other refrigerated and frozen foods shipped in a temperature-abused trailer, affecting 1,721 cases total. No illnesses have been reported.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend because the product contains kratom, an unapproved food additive, and has a pH level exceeding the required maximum for acidified products.
Gaws Gourmet Foods is recalling Gaw's Salami & Cheese Bagel 6oz due to undeclared sesame allergen. Affected products have use-by dates from November 28 through December 15, 2023.
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
Votrient (pazopanib hydrochloride) 200 mg tablets are being recalled nationwide. Three lot numbers failed to meet dissolution specifications.
E.A. Sween Co. is recalling Deli Express Deli Club sandwiches (lot U023236) due to label mix-up with inaccurate required label information. The recall affects 31,550 units distributed across 19 states.
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
BC Gourmet USA, Inc. is recalling 81,312 units of Hungry Root Marinara Sauce due to yeast and mold contamination. Affected products were distributed in California, New Jersey, and Indiana.
Ben E Keith Foods recalls approximately 1,721 cases of frozen and refrigerated food products due to temperature abuse during distribution to food services.
Ben E Keith Foods recalls 1721 cases of frozen bread products that experienced temperature abuse during truck shipment to food services. Products include sandwich bread, dinner rolls, and hamburger buns.
Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.