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.
Blistex Inc is recalling Odor-Eaters brand Tolnaftate 1% antifungal spray powder nationwide due to benzene contamination. The recall affects approximately 243,386 cases distributed in the USA, Canada, and Korea.
ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.
TGD Cuts, LLC is recalling Mixed Fruit Melon Medley Chunk products due to potential Salmonella contamination. Affected products with use-by dates from November 2 to November 23, 2023 were distributed in eight states.
Renaissance Food Group is recalling Large Fruit Tray with Dip products distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina due to potential Salmonella contamination. Consumers who purchased affected products should not consume them.
Nurse Assist is recalling sterile water and saline irrigation products due to lack of sterility assurance. Use of nonsterile products could result in infection.
TGD Cuts, LLC is recalling various mixed fruit products distributed across eastern states due to potential Salmonella contamination.
ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.
HMC Farms Signature Farms Nectarines in 2lb bags are recalled due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and to Mexico, Canada, and Taiwan.
ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.
Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.
HMC Farms Nectarines 4lb bags are recalled due to potential Listeria monocytogenes contamination. The recall affects 26 US states, Mexico, Canada, and Taiwan.
HMC Farms White Peaches (4lb box) have been recalled due to potential Listeria monocytogenes contamination. Consumers should not consume this product.
Aviator Dehydrated Tomato Halves are recalled due to undeclared sulfites. Sulfites are allergens that can trigger reactions in sensitive individuals.
HMC Farms Peaches Signature Farms 2lb bags have been recalled due to potential Listeria monocytogenes contamination. The affected product was distributed widely across the United States and internationally.
Renaissance Food Group is recalling Fruit Medley products in 9 oz and 18 oz sizes due to Salmonella contamination. The affected products were distributed to Alabama, Georgia, Florida, North Carolina, and South Carolina.
TGD Cuts, LLC is recalling Mixed Fruit Cube 1/2" products due to potential Salmonella contamination. The recall affects units distributed in Pennsylvania, New Jersey, Maryland, West Virginia, South Carolina, Virginia, Delaware, North Carolina, and New York.
THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.
Kwik Trip Mixed Fruit Tray is recalled for potential Salmonella contamination. Approximately 77,013 units were distributed in six states with sell-by dates from Nov. 4 to Dec. 3, 2023.
Karl Storz Endoscopy is recalling injection needles and cannulas because the manual cleaning process may not effectively remove contaminants, potentially exposing patients to infection risk.
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Siemens RAPIDPoint 500 cartridges may produce inaccurate sodium measurements in blood samples, potentially delaying diagnosis or causing inappropriate treatment. The sodium sensor may show a negative bias, affecting patient care.
Fagron, Inc. is recalling 46 containers of Nystatin 500 MU bulk powder used for prescription compounding due to an incorrect assay value on the product label. The mislabeled strength could affect proper compounding of patient medications.
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.