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.
Windy Hill Chocolate LLC recalls Midnight Bonbon due to undeclared allergens including soy, milk, and tree nuts. Consumers with allergies to these substances should not consume this product.
Borris Brothers is recalling Smoked Wahoo Dip due to undeclared Yellow #5 (tartrazine), an allergen that may affect consumers with sensitivity. The recall affects 112 containers distributed in Florida.
Medtronic is recalling Distractor Rack devices used in spinal surgery due to manufacturing defects that may prevent proper device operation. Two lot numbers are affected and were distributed to facilities in Indiana, Connecticut, and Nebraska.
Ajikal 44g Kotsubukko snacks containing undeclared coconut were distributed across multiple US states and Canada. Consumers with a coconut allergy should not consume this product.
DAISO dried squid snack recalled because fish other than squid is present but not listed in ingredients or allergen statement. Consumers with fish allergies are at risk.
Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.
Bard Mission Disposable Biopsy Instrument Kit has an incompatibility defect where the cannula is oversized relative to the needle, preventing proper insertion and tissue access. This could cause procedure delays and insufficient tissue collection.
Windy Hill Chocolate LLC recalled Pear Almond chocolate products due to undeclared soy, milk, and tree nut allergens. Consumers with allergies to these ingredients should not consume the product.
Ito Confectionery Langley chocolate cream (6-pack, UPC 4901050138605) is recalled because shea nut allergen is not declared on the product label.
ZB Importing LLC is recalling Ziyad cinnamon powder (4.5 oz jars) from lot 21321G2 due to elevated lead levels. The recall affects 3,456 units distributed across multiple U.S. states and territories.
Windy Hill Chocolate LLC is recalling Grand Marnier chocolate due to undeclared allergens: soy, milk, and tree nuts. Consumers with allergies to these substances should not consume the product.
Windy Hill Chocolate LLC recalls Key Lime Bonbons due to undeclared allergens (soy, milk, tree nuts). Consumers with allergies should not consume this product.
Kajitani Food Congeri Crispy crackers (104g, UPC 4901332108661) contain coconut but do not list it in the ingredients or allergen statement. Consumers with coconut allergies may be at risk; approximately 2,199 units were distributed to retail locations across multiple US states and Canada.
Windy Hill Chocolate LLC is recalling Mango Bonbon due to undeclared allergens. The product contains soy, milk, and tree nuts not listed on the label.
Ajikal Age Ichiban 97g snacks are being recalled due to undeclared coconut, a tree nut allergen that can cause allergic reactions. The affected product was distributed across multiple US states and Canada.
Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.
Windy Hill Chocolate LLC is recalling pistachio products due to undeclared allergens (soy, milk, tree nuts) that may cause allergic reactions in sensitive consumers.
Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.
Bio-Rad Laboratories is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (Lot 301538) nationwide because they were packaged with incorrect conjugate. This could result in false-positive and false-negative test results.
Windy Hill Chocolate LLC is recalling Peanut Butter Praline due to undeclared allergens: soy, milk, and tree nuts. Consumers with these allergies should not consume the product.
Windy Hill Chocolate LLC is recalling Chocolate Covered Oreos due to undeclared soy, milk, and tree nut allergens. The product was distributed domestically and poses a risk to consumers with allergies to these ingredients.
BD Pyxis automated dispensing cabinet software versions 1.7.0 through 1.7.4 experience download failures causing partial loss of patient information and transaction data. This may result in dispensing incorrect medication doses, allergenic medications, or discontinued medications.
Windy Hill Chocolate LLC is recalling Ginger Lime cookies due to undeclared allergens—soy, milk, and tree nuts. Consumers with sensitivities or allergies to these allergens should not consume the product.
Daisho crab miso soup is being recalled because the product contains shrimp but the label warns only for crab, posing a risk to consumers with shrimp allergies. Products were distributed across multiple US states and Canada.
Dr. Rico Perez Super Kids Colostrum chewable tablets are being recalled because the product contains milk but does not declare this allergen on the label. Consumers with milk allergies may be at risk.