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.
Newly Weds Foods, Inc. is recalling Starch WPC Blend 30lb bags due to potential Salmonella contamination in the ingredient. The recall affects 4,020 pounds of product distributed in Florida, Illinois, and Texas with lot numbers MT712282 and MT712283.
Irvington Seafood is recalling claw crab meat due to Listeria monocytogenes contamination found during product testing. The affected product was distributed in Mississippi and Alabama.
Irvington Seafood, Inc. is recalling Lump Crab Meat due to Listeria monocytogenes contamination identified in finished product testing. The recalled product was distributed in Mississippi and Alabama.
Irvington Seafood is recalling Jumbo Crab Meat due to Listeria monocytogenes found during product testing. Affected packages distributed in Mississippi and Alabama should not be consumed.
GRANDE CHEESE COMPANY is recalling Grande Ultra 9100 Functional Whey Protein Isolate (SKU 32131) due to possible Salmonella contamination. The recall affects 1.7 million pounds distributed to 24 U.S. states and international markets.
Mt. Capra Goat Milk Formula Recipe Kit recalled for marketing as infant formula without FDA premarket notification.
Grande Lactose (SKU 30601) is being recalled due to possible Salmonella contamination. The affected product was distributed across multiple US states and internationally.
Grande Bravo 500 Functional Whey Protein is recalled due to possible Salmonella contamination. The product was distributed across 24 US states and internationally to Canada, Ecuador, and Japan.
Kerry, Inc is recalling BrS8 RODIZIO Seas No MSG seasoning ingredient due to potential Salmonella contamination. The affected product was distributed to multiple U.S. states and Canada.
Grande Bravo 550 Functional Whey Protein is being recalled due to possible Salmonella contamination. Affected batches ANV508-1 and ANV508-3 were distributed across 24 U.S. states and internationally.
Grande Cheese Company is recalling Grande Ultra 8000 Nutritional Whey Protein Isolate due to possible Salmonella contamination. The affected batches include AOE813-1 through AOE813-4 and AOF840-1 through AOF840-4.
Newly Weds Foods, Inc. is recalling 50-pound bags of breader (lot CD032324M) due to potential Salmonella contamination in an ingredient. The product was distributed to customers in Florida, Illinois, and Texas.
Grande Cheese Company is recalling Grande Bravo 300 Functional Whey Protein (SKU 32102) due to possible Salmonella contamination. The affected product was distributed across multiple US states and internationally.
Aesculap Inc is recalling Aeos Robotic Digital Microscope models with Product Code PV010 due to failure of the integrated safety mechanism. The robotic arm may drop more than 10 cm from its original position after the emergency stop button is pressed.
Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.
Canon Medical MRI systems are being recalled because the terminal block securing the power cable may disconnect, potentially causing electrical arcing and fire. 153 units are affected across the United States and Puerto Rico.
B Braun Medical Inc is recalling 108,811 units of Stimuplex A anesthesia needles because the devices are labeled as DEHP-free but the glue contains traces of DEHP.
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.
Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.
B Braun Medical Inc is recalling Stimuplex A injection needles because the devices are labeled as DEHP-free, but the glue used contains traces of DEHP. The recall affects 20,850 units distributed in the US and Canada.
Grande Cheese Company is recalling Grande Lactose SKU 30600 due to possible Salmonella contamination across 24 U.S. states and three countries. No illnesses have been reported.
GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.
The CORI Starter Kit surgical system may experience display flickering from a software tracking error, potentially causing surgical delays during orthopedic procedures.
Wondfo USA is recalling 102,500 units of IMCO Strep A Rapid Test Kits due to unauthorized distribution for at-home, over-the-counter, and direct-to-consumer use.