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.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
LuLu Chinese Express Sweet and Sour Shrimp with Fried Rice is being recalled because soy allergen information is missing from the label. Consumers with soy allergies face a serious health risk.
Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
The W.S. Badger Company is recalling Badger 50 mineral sunscreen tins lacking the complete drug facts label, barcode, and directions for use. The recall affects 4,834 tins distributed nationwide.
Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.
Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.
Cal Yee's Dark Chocolate Raisins recalled for undeclared milk allergen. Product distributed to retail stores in California and online customers in California and Pennsylvania.
Braga Fresh Foods LLC is recalling Marketside broccoli florets sold at Walmart due to potential Listeria monocytogenes contamination. Consumers should not eat the product.
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
Shoppers-Plaza is recalling FOUZEE SugarLin Herbal Formula capsules because FDA testing found undeclared metformin and glyburide. The product was marketed without FDA approval.
Cal Yee's New Orleans Hot Mix contains undeclared wheat and soybean oil. The product was distributed to retail stores in California and through online and phone orders in California and Pennsylvania. Consumers with these allergies should not consume the product.
Acme Smoked Fish Corp. is recalling KIRKLAND Signature Smoked Salmon due to Listeria monocytogenes contamination. The product was distributed to retail locations in Florida.
Cal Yee Farm LLC is recalling Tropical Trail Mix due to undeclared milk, a common allergen. The product was sold at 2 California retail stores and via online/phone orders in California and Pennsylvania.
Cal Yee Farm LLC has recalled 8-oz bags of Cal Yee's Dark Chocolate Walnuts because they contain undeclared milk. The product was sold at 2 California retail stores and through online/phone orders in California and Pennsylvania.
Cal Yee Farm is recalling Dark Chocolate Apricots due to undeclared milk. The product was distributed to retail stores and online customers in California and Pennsylvania.
Cal Yee's Yogurt Coated Almonds recalled for undeclared milk. Voluntary recall covers products distributed to retail stores and online/phone orders in California and Pennsylvania.
Cal Yee's Dark Chocolate Almonds contain undeclared milk and are being recalled. The product was distributed at 2 California retail stores and online in California and Pennsylvania.
Cal Yee Farm LLC is recalling Cal Yee's Cajun Sesame Hot Sticks (1-lb bags) due to undeclared wheat and soybean oil. The product was sold in California retail stores and through online/phone orders in California and Pennsylvania.
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Cal Yee Farm LLC recalled Cal Yee's Dried Mangos with Chili due to undeclared Yellow No. 5, an allergen. The product was distributed to two California retail stores and customers in California and Pennsylvania.