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.
Lyons Magnus LLC is recalling GFS Harvest Valley Grape Juice in 4 fl oz cups due to signs of bloating in containers. Consumers in multiple states should not consume and should dispose of the product safely.
Lundbeck LLC recalls Sabril (vigabatrin) oral solution nationwide due to potential cross-contamination. The recall affects 10,543 cartons.
Siemens Healthcare Diagnostics is recalling Atellica CH Total Protein II due to reagent carryover affecting magnesium test accuracy. The recall covers all lots (13,071 units) distributed nationwide and internationally.
C & S Wholesale Grocers is recalling 29,469 cases of Gourmet Garden herb and spice products sold at Stop & Shop stores in the New York Metro region due to improper temperature storage. Consumers should discard these products.
Olympus is updating labeling for 363 Visera Hysterovideoscope devices nationwide to correct ethylene oxide sterilization parameters and eliminate certain reusable cleaning brush recommendations.
Contract Pharmaceuticals is recalling Clindamycin Phosphate Topical Solution USP 1% due to defective containers that leak under the cap. The recall affects 11,350 bottles distributed nationwide.
Real Kosher Ice Cream's Soft Serve on the Go Caramel Vanilla ice cream (8 fl oz) may be contaminated with Listeria monocytogenes. The product was distributed across multiple US states and internationally.
Freshy Foods, LLC is recalling Team Fresh & Go Mixed Fruit Cup due to potential Listeria monocytogenes contamination in 249 units distributed to facilities in Florida, Louisiana, and Mississippi.
Soft Zero on the Go brand Lite Peanut Butter ice cream is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed across multiple U.S. states and internationally.
Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Vanilla Chocolate ice cream due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and several countries.
Freshy Foods is recalling Team Fresh & Go Cantaloupe Cups due to potential Listeria monocytogenes contamination. The affected product was distributed in Florida, Louisiana, and Mississippi.
Draeger Medical is recalling 11,621 Carina Sub-Acute Care Ventilators because polyurethane components emit 1,3-Dichloropropan-2-ol at levels exceeding safe limits during extended use in pediatric patients.
Real Kosher Ice Cream, Inc. is recalling Soft Serve on the Go brand Strawberry Mango Sorbet due to potential Listeria monocytogenes contamination. The product was distributed across multiple U.S. states and international locations.
Freshy Foods, LLC is recalling Team Fresh & Go Pineapple Cups due to potential Listeria monocytogenes contamination. The recall affects 214 units distributed in Florida, Louisiana, and Mississippi.
Real Kosher Ice Cream recalls Soft Serve on the Go Peanut Butter ice cream due to potential Listeria contamination. Consumers should discard the product or return it.
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.
Bickel's Snack Foods Inc is recalling Butter Flavored Popcorn because the product contains undeclared milk. The recall affects approximately 6,048 bags distributed in Georgia and nationwide retail stores.
Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.
Every Plate is recalling Green Curry Paste (1 oz, 28g) in meal codes 87 and 116 due to spoilage from temperature abuse. The affected product was distributed to customers in eight states.
Tailor Made Compounding is recalling 9 vials of Semaglutide/Cyanocobalamin 2mg/0.4mg/mL due to inability to assure sterility. The product was distributed nationwide.