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.
Shakespeare's Pizza recalls Four Cheese Pizza due to undeclared wheat allergen. The product was distributed in Missouri, Kansas, and through online sales.
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
Island Snacks, Inc. is recalling The Candy Shop Rainbow Belts because the product is labeled gluten-free but contains modified wheat flour. This poses a risk to consumers with celiac disease or gluten sensitivity.
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
La Michoacana Rompope ice cream bars are being recalled due to undeclared Yellow #5, Yellow #6, and Red #40. The product was distributed only in Florida.
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Zeus Scientific recalls ZEUS ELISA Parvovirus B19 IgM test kits due to an unapproved modification to the test conjugate that was implemented without FDA review and approval.
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes due to incorrect pouch labels. Pouches are mislabeled as Right Angle Cutting Loop Electrodes but contain the correct Roller Bar product.
Vero Biotech is recalling GENOSYL DS Generation 3 cassettes that failed to meet manufacturing flow specifications. The recall affects 2 units distributed in Arizona and Florida.
Wilcox SUPER PREMIUM Super Java ice cream (1.5 QT and Pint) may be contaminated with Listeria. Affected products were distributed in VT, NH, MA, and NY with Best By/Sell By dates from 9/13/24 to 11/14/24.
Wilcox Ice Cream Bar (Dairy Based) - Vanilla may be contaminated with Listeria monocytogenes. Consumers with best-by dates from September 15, 2024, through November 14, 2024, should not consume the product.
Cut Fruit Express is recalling mixed fruit products containing cantaloupe that may be contaminated with Salmonella. The products were distributed in Illinois, Minnesota, and Wisconsin.
Wilcox Premium Mint Chocolate Chip ice cream sold in VT, NH, MA, and NY has been recalled due to potential Listeria monocytogenes contamination. Consumers should discard the product or return it to the point of purchase.
Wilcox Premium Sea Salt Caramel ice cream is being recalled for potential Listeria monocytogenes contamination. Affected products with best-by dates of 9/14/24 to 11/14/24 were distributed in VT, NH, MA, and NY.
PACIFIC TRELLIS FRUIT, LLC is recalling Malichita brand whole cantaloupes in 9-count and 12-count packages due to potential Salmonella contamination. The recall affects 4,872 cases distributed in Wisconsin, Oklahoma, Illinois, Texas, California, and Canada.
Maggi 2-Minute Noodles sold in California are being recalled for undeclared peanut allergen. Consumers with peanut allergies should not consume this product.
Wilcox Ice Cream Bars (Espresso) sold in VT, NH, MA, and NY may be contaminated with Listeria monocytogenes. Consumers should not consume the product.
Wilcox SUPER PREMIUM Chocolate ice cream in 1.5 QT and Pint sizes is recalled for potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with Best By/Sell By dates from 9/13/24 to 11/14/24.
Houdini Inc. recalls Acorn Raspberry Creme Filled Cookies from gift baskets for undeclared tree nuts. Approximately 4,875 cookies across 1,168 gift boxes were distributed nationwide. Consumers with tree nut allergies should not consume this product.
Wilcox Ice Cream Bar (Black Raspberry) is being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.
Wilcox Ice Cream is recalling Maple Cream in 1.5 quart and pint sizes due to potential Listeria monocytogenes contamination. The affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September 13 to November 14, 2024.
Houdini Inc. is recalling Acorn Raspberry Creme Filled Cookies found in gift baskets due to undeclared tree nuts. The cookies were distributed nationwide to all U.S. states.