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.
DAISO CALIFORNIA WAREHOUSE is recalling IWATSUKASEIKA Soybean Flavor snacks because wheat was not declared on the label. Consumers with wheat allergies should not consume this product.
Delsam Pharma's Artificial Eye Ointment is being recalled for bacterial contamination in unopened tubes. FDA analysis found non-sterility defects in approximately 50,000 units.
Shinsei Additive Free Sesame Sauce is being recalled because wheat allergen was not declared on the product label. Consumers with wheat allergies who consume this product may experience allergic reaction.
MEITO An extra Stick Powdered Lemon Tea is recalled because the product contains milk that is not declared on the label. Consumers with milk allergies who have purchased this product should not consume it.
MEITO Lemon Tea 4-pack is being recalled because milk allergen was not declared on the label. Consumers with milk allergies should not consume this product.
Fuyouyakuhin Fruitsaojiru 3g juice powder is being recalled because cashew and almond allergens were not declared on the label. Consumers with allergies to these tree nuts should not consume this product.
SENNARIDO Green Snack Pistachio-Wasabi Flavor (90g) is recalled because soy is not declared on the label. Approximately 10,986 units were distributed across California, Washington, Nevada, Texas, New York, New Jersey, and Canada.
DAISO CALIFORNIA WAREHOUSE is recalling IWATSUKASEIKA Ajishirabe Rice Crackers because the label fails to declare wheat. Wheat is a major allergen that can cause severe allergic reactions in sensitive individuals.
DAISO CALIFORNIA WAREHOUSE is recalling SENNARIDO Green Snack Pistachio 90g because the product contains undeclared soy, a major food allergen that poses allergic reaction risk to sensitive consumers.
ITOSEIKA chocolate chip cookies are being recalled due to undeclared milk allergen on the label. Consumers with milk allergies should not consume this product.
Kanro Non sugar coffee candy is recalled because coconut was not declared on the label, posing a risk to consumers with coconut allergies.
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.
Datascope Corp. is recalling 669 Cardiosave IABP Safety Disks due to a performance defect that may reduce balloon inflation during cardiac support therapy. The affected devices may not provide adequate augmentation to patients requiring mechanical circulatory support.
BA Sports Nutrition is recalling BODYARMOR SportWater due to potential plastic pieces in the product. The recall affects approximately 21 million bottles distributed across 11 states.
Daiso California Warehouse is recalling Meito Milk Cocoa (12gX5P, UPC 4902757444709) because coconut allergen is not declared on the label. Consumers with coconut allergies should discontinue use and return the product.
DePuy Orthopaedics is recalling Attune Revision LPS Tibial Insert devices (Lot JP9016) because they received excessive gamma radiation during manufacturing, which may compromise material properties.
Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.
DePuy Orthopaedics recalls 7 units of Attune Revision LPS Tibial Inserts (Part 151760118, Lot JP6452) distributed worldwide due to excessive gamma radiation during manufacturing. This overage may result in material property changes.
DePuy Orthopaedics is recalling Attune Posterior tibial insert implants that received excessive gamma radiation during manufacturing, which may degrade the material properties of the knee replacement component.
Onishi Foods Alpha Rice Matsutake Mushroom Rice is being recalled because the label does not declare coconut, a major allergen. The recall affects 733 units distributed in multiple US states and Canada.
Biomet recalled 12 units of its G7 Acetabular System 40mm Size D Liner because the actual implant is a 38mm Size C. The mismatch between outer labeling and the actual implant could result in wrong-size component placement during surgery.
Igarashiseimen Kitakata Spicy Umakara Ramen is being recalled because coconut allergen is not declared on the label. Consumers with coconut allergies should not consume this product.
Kinjo Seika Potato Yokan confection is being recalled because coconut, a major allergen, was not declared on the label. Consumers with coconut allergies should not consume this product.
Russell Stover Sugar Free Peanut Butter Cups are being recalled for undeclared tree nuts (pecans) on the outer packaging. The mislabeling poses a risk to consumers with tree nut allergies.