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.
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.
JLM Manufacturing LLC is recalling JLM Sesame Sticks Mix (11oz tubs) because units may contain undeclared cashew, a common allergen. The recall affects 307 cases distributed across 18 states.
Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.
Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
JLM Sunflower Meat Roasted/Salted is recalled for undeclared cashew allergen affecting 175 cases across 18 states. Consumers with tree nut allergies should not consume.
Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.
Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.
Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.
Rama Food Manufacture Corp is recalling Pad Thai Noodles (lot 1128A1, manufactured 09/26/22) due to improper cooling and refrigeration during manufacturing. The products may pose a health risk.
Rieckhoff Family Businesses is recalling Gourmet Old-Fashioned Caramel Holiday Popcorn boxes because the label falsely claims the product is gluten-free, though it contains wheat and barley.
Shemshad Food Products, Inc. is recalling Pomegranate Fruit Roll Ups due to sodium content measured at 131% of the declared level. The product was distributed to 8 retail locations in the Los Angeles area.
Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
Old Europe Cheese, Inc. is recalling multiple brands of triple creme brie cheese due to potential contamination with Listeria monocytogenes. The recall affects products distributed across the United States and Mexico.
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
Old Europe Cheese, Inc. is recalling multiple brands of herb-flavored Brie cheese due to potential contamination with Listeria monocytogenes. Affected products have best-by dates ranging from September 28 to December 14, 2022.
Mariscos Bahia Inc is recalling Fresh Salmon Deep Skin Fillets due to possible salmonella contamination. The affected product was distributed to restaurants in Arizona and California.
Old Europe Cheese Inc. is recalling multiple brands of soft cheeses (Brie and Camembert) due to potential Listeria monocytogenes contamination. Affected products were distributed to multiple U.S. states and Mexico with best-by dates from September to December 2022.
Old Europe Cheese is recalling Joan of Arc 2.2 lb peppercorn wheel cheese due to potential Listeria monocytogenes contamination. Affected products have best-by dates from September 28 to December 14, 2022.
Old Europe Cheese is recalling Reny Picot and ST Randeaux double-crème Brie cheeses due to potential Listeria monocytogenes contamination. Affected products have best-by dates from September 28, 2022 to December 14, 2022.