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.
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.
Gaws Gourmet Foods is recalling Gaw's Ham & Cheddar Bagels due to undeclared sesame. The product label does not list sesame, posing a risk to consumers with sesame allergies.
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events 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.
Sienna Bakery Chocolate Decadent Brownies are being recalled due to undeclared peanuts. Consumers with peanut allergies should not consume this product.
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.
Wilcox Premium Salted Caramel Turtle ice cream (3-gallon) may be contaminated with Listeria monocytogenes. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates September 14–November 14, 2024.
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.
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.
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
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.
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.
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 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.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
Ben E Keith Foods is recalling frozen and refrigerated shrimp and other food products that were temperature abused while stored in a food trailer. The products were distributed to food service establishments.
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.