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.
Wilcox Premium Triple Chocolate Cookie ice cream is recalled for potential Listeria monocytogenes contamination. Affected products in Vermont, New Hampshire, Massachusetts, and New York have best-by dates from September through November 2024.
Cut Fruit Express is recalling mixed fruit products containing cantaloupe due to potential Salmonella contamination. Products were distributed in Illinois, Minnesota, and Wisconsin.
Wilcox Yogurt - Maple Cream pints sold in Vermont, New Hampshire, Massachusetts, and New York are recalled due to potential Listeria monocytogenes contamination.
Leonardo's Gelato Mint Chocolate Chip (pints and 4 oz cups) may be contaminated with Listeria monocytogenes. Products were distributed in VT, NH, MA, and NY with Best By dates from August 28–November 14, 2024.
Wilcox SUPER PREMIUM Salted Caramel Brownie ice cream may be contaminated with Listeria monocytogenes. The recall affects products sold in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September 13 to November 14, 2024.
Crown Jewels Produce Company is recalling Malichita/Z Farms Cantaloupes due to potential Salmonella contamination. The affected cantaloupes were distributed in California and Ohio.
Wilcox Premium Strawberry ice cream in multiple sizes distributed in VT, NH, MA, and NY may contain Listeria monocytogenes. Consumers should discard affected products.
The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.
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.
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.
Burn Boot Camp AFTERBURN grass-fed whey protein bars (Triple Chocolate with Almond Butter) are being recalled due to foreign material including disposable hairnet, shrink wrap, and parchment paper found in some units. Affected lots are 181, 184, and 187.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
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.
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 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.
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.
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.
The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.
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.
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.
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
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.
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.