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.
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Tillamook Chocolate Peanut Butter ice cream cartons were mislabeled and contain Waffle Cone Swirl ice cream with undeclared wheat and soy allergens. The affected cartons were distributed in Idaho and Washington.
Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.
Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.
Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.
Jarman's Midwest Cleaning Systems recalled 1,276 gallons of isopropyl alcohol hand sanitizer nationwide due to manufacturing deficiencies and potential methanol contamination risk found at the production site.
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.
Tastykake Chocolate Kandy Kakes are being recalled due to undeclared peanuts. The product poses a serious risk to individuals with peanut allergies.
Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.
TETAS Mireya, SABOR Galleta Oreo cookies are being recalled due to undeclared soy and wheat allergens. Consumers with soy or wheat allergies should not consume this product.
A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.
DIBE LLC is recalling TETAS Mireya candy due to undeclared soy and walnut allergens. Consumers with allergies to these ingredients should not consume the product.
DIBE LLC is recalling TETAS Mireya SABOR Galleta Maria cookies due to undeclared soy and wheat allergens. Consumers with allergies to these ingredients should not consume the product.
Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.
Meijer Inc is recalling Meijer Express Dark Chocolate Covered Almonds due to undeclared milk, a serious risk for consumers with milk allergies. The recall affects 9,030 units in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.
The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.
A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.
Olam Food Ingredients is recalling Onion Powder Premium sold in bulk fiber bags due to potential Salmonella contamination. Affected product was distributed to Canada, Arkansas, and Illinois.
Meijer Inc is recalling Frederik's by Meijer Dark Chocolate Almonds due to undeclared milk. The product was distributed to Meijer stores in six Midwest states.
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.
Sodexo is recalling simply to go Strawberry Yogurt Parfaits due to undeclared soy lecithin and brown sugar syrup. Consumers with soy allergies may be at risk.