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.
Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.
An incorrect security key prevents the NuVasive Pulse III system from connecting to remote monitoring during spinal, thoracic, and extremity surgeries. Affected facilities should contact NuVasive for corrective action.
Akorn is recalling 45,117 bottles of Atropine Sulfate Ophthalmic Solution because stability testing found viscosity measurements out of specification. The affected product should not be used.
73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.
GFA Production is recalling Adventure First Aid 1.0 kits containing Easy Care After Burn Cream due to confirmed bacterial contamination found in FDA testing. The affected product was distributed nationwide and in Canada.
GFA Production is recalling Easy Care First Aid Kits distributed nationwide and in Canada due to bacterial contamination of included After Burn Cream packets. The FDA confirmed the presence of Bacillus lichenformis and Bacillus sonorensis.
Easy Care first aid burn cream distributed nationwide and in Canada is recalled due to FDA-detected contamination with Bacillus lichenformis and Bacillus sonorensis. The product should not be used.
Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.
FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.
Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.
GFA Production's Easy Care First Aid 25 Person kits are being recalled nationwide due to contamination with Bacillus bacteria. The affected first aid cream packets could pose a risk if applied to open wounds.
The FDA is recalling Easy Care First Aid kits containing After Burn Cream due to microbial contamination. The affected product was distributed nationwide and in Canada with lot number W06H15 (expiration August 15, 2024).
Wegmans bakery tiramisu products contain undeclared wheat not listed on the label. The products are marked as made with no gluten-containing ingredients but do not declare wheat as an allergen.
Fullei Fresh brand alfalfa sprouts are recalled due to possible contamination with Shiga toxin-producing E. coli. The recall affects 333 cases distributed in Florida, lot number 336.
CVS First Aid Home, First Aid Kit burn cream packets have been recalled due to bacterial contamination. The product contains Bacillus lichenformis and Bacillus sonorensis bacteria, creating a risk when applied to wounds or burns.
GFA Production is recalling Easy Care First Aid 10 Person First Aid Kits because the included After Burn Cream packets are contaminated with Bacillus bacteria. Contamination was identified through FDA laboratory testing.
A first aid kit containing topical burn cream has been recalled due to bacterial contamination with Bacillus species. The product (Lot W06I20) was distributed nationwide and in Canada.
Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.
Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.
Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.
The FDA is recalling Adventure First Aid 1.5 first aid kits due to bacterial contamination found in the included burn cream packets. The contamination was identified through FDA laboratory testing.
James Farm brand frozen red raspberries from Chile may be contaminated with Hepatitis A Virus. The product was distributed to food service facilities in the Northeast.
The FDA is recalling Easy Care First Aid Kits with contaminated After Burn Cream packets distributed nationwide and in Canada. Lab testing identified Bacillus lichenformis and Bacillus sonorensis contamination.
Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
Ameripack Foods LLC is recalling Chocolate Chunk Brownies (UPC 4122077413) due to undeclared soy and egg allergens. Consumers with allergies to these ingredients should not consume the product.