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.
Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.
Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.
Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.
Fudgeamentals Chocolate Fudge Bites (8 oz) are being recalled because they contain undeclared tree nuts. Consumers with tree-nut allergies are at risk of allergic reaction.
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.
Heritage Pharmaceuticals' desmopressin acetate tablets (0.2mg) have been recalled nationwide due to subpotency. The voluntary recall affects 13,805 bottles; no illnesses have been reported.
Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.
Amy's Kitchen is recalling Gluten Free Bean and Cheese Burritos (Lot 30H0922, best before 08/2024) due to potential plastic pieces in the product. Approximately 5,134 cases were distributed to 18 U.S. states.
Noven Pharmaceuticals recalls 3,977 boxes of Daytrana methylphenidate transdermal patches nationwide due to defective adhesive properties in lot 91316. Affected patches may fail to adhere properly or deliver medication inconsistently.
Coolhaus Dairy Free Cookie Dough Lyfe frozen dessert sandwiches recalled due to coliform detected in lab samples. Product distributed to select retailers in Texas, Maryland, Colorado, and California.
Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.
Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.
A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.
Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.
Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.
3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.
Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.
DAISO CALIFORNIA WAREHOUSE is recalling Tiramisu Twist Cookie 3.4 oz. packages due to undeclared tree nuts. Consumers with tree nut allergies face allergic reaction risk if they consume this product unknowingly.
Seed Ranch Flavor Co. is recalling Everything But The Sushi & Dumplings sauce due to undeclared soy allergen. Approximately 11,449 bottles were distributed nationwide and internationally.
Umami Everyday Sauce is being recalled due to undeclared soy allergen. This poses a risk to consumers with soy allergies and sensitivities.
Whele LLC is recalling approximately 4,034 Mighty Bliss Electric Heating Pads due to burn and shock hazards. The firm received complaints of burns, mild electrical shocks, and skin irritation.