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.
El Ruisenor De Mexico, Inc. is recalling 59 pounds of dried pears because they contain undeclared sulfites, a common allergen.
Techno-Path is recalling Multichem AE quality control material because stability drift affects the Ammonia analyte, potentially delaying diagnostic results.
El Ruisenor De Mexico, Inc. is recalling 217 pounds of dried kiwi slices due to undeclared sulfites, Yellow #5, and Blue #1.
El Ruisenor De Mexico, Inc. is recalling Jovy Gummy Bears Neon due to undeclared artificial dyes. The product is distributed primarily in California and limited areas in other states.
Walker Foods is recalling Marca El Pato Salsa para Enchiladas because it contains undeclared salt, garlic, and onions. The product was distributed to 32 customers nationwide.
El Ruisenor De Mexico, Inc. is recalling 102 pounds of Whole Pitted Dried Apricots because they contain undeclared sulfites, a known allergen.
El Ruisenor De Mexico, Inc. is recalling Honey Nut Granola because it contains undeclared almond and cashew ingredients.
El Ruisenor De Mexico, Inc. is recalling 69 pounds of Dried Diced Pineapple because the product contains undeclared sulfites. The recall affects customers in California and several other states.
El Ruisenor De Mexico, Inc. is recalling Fritura Lagrimita / Teardrop Wheat Snack because it contains undeclared wheat, Yellow #6, and soy.
El Ruisenor De Mexico, Inc. is recalling Fritura mixed dry fruit because it contains undeclared wheat, Yellow #5, and Yellow #6.
Beckman Coulter is recalling 92 Optima ultracentrifuge rotors that may break during operation, potentially destroying samples and exposing personnel to biohazards.
El Ruisenor De Mexico, Inc. is recalling Milk Chocolate Covered Raisins due to undeclared milk and soy allergens. The product was distributed primarily in California and limited areas in six other states.
El Ruisenor De Mexico, Inc. is recalling 225 pounds of dried papaya spears because the product contains undeclared Yellow #6 and sulfites.
El Ruisenor De Mexico, Inc. is recalling Jovy Gummy Worms (Regular) because the product contains undeclared artificial dye ingredients.
El Ruisenor De Mexico, Inc. is recalling Tropical Trail Mix because it contains undeclared peanuts, almonds, sulfites, and Yellow #6.
El Ruisenor De Mexico, Inc. is recalling air-dried apple rings because they contain undeclared sulfites, a common allergen.
Medline Industries is recalling specific medical convenience kits because they are difficult to remove and leave adhesive residue on patient skin.
Boston Scientific is recalling 382 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
El Ruisenor De Mexico, Inc. is recalling 237 pounds of whole wheat flour due to an undeclared wheat allergen. The product was distributed primarily in California and limited areas in six other states.
El Ruisenor De Mexico, Inc. is recalling Jovy Watermelon Gummy Rings because they contain the undeclared allergen Red #40.
Medline is recalling 108 C-Section Tray kits because they are difficult to remove from patients and leave adhesive residue on the skin.
Medtronic is recalling InterStim SureScan MRI Leads because selecting an incompatible lead or extension prevents the system from working as intended.
Medline Industries is recalling 10 FETOSCOPY CDS-LF medical convenience kits because they are difficult to remove from patients and leave adhesive residue on the skin.
Pritam International is voluntarily recalling Brush Buddies toothpaste nationwide due to CGMP deviations. No illnesses or injuries are reported.
Gearharts Fine Chocolates is recalling 4,703 pieces of chocolate because broken glass was found in finished product. The recall covers 4oz and 8oz packages shipped to 17 states.