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.
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
Wegmans Caramel Apple Pecan Topped Brie Cheese, small 13 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Wegmans Assorted Cheese Flight, sold by the pound, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Wegmans Medium Camembert Soft Ripened Cheese, 8.8 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes, 10 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.
DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.
Ultra Violette Velvet Screen SPF 50 mineral sunscreen is recalled nationwide after testing produced inconsistent SPF results ranging from SPF 4 to 64. 49,275 tubes are affected.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in 50-tablet unit dose cartons for AvKare, are recalled nationwide for the presence of a foreign substance. 1,512 cartons are affected.
Peanut rounds in 2.25 oz and 3 oz sizes are recalled for an undeclared soy allergen. The recall covers 960,000 units across ten states.
TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Boss Drills, 6.5 mm, are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 907 units are affected.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Zydus Chlorpromazine Hydrochloride Tablets, USP, 50 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Wasatch Photonics Raman spectrometers are recalled after two potential laser safety failure modes were identified in the product design. The firm states the modes have never been found to occur. 192 units are affected.
QuickVue Dipstick Strep A Tests are recalled because the test has the potential for false positive results. 22,470 units are affected.
Zydus Chlorpromazine Hydrochloride Tablets, USP, 25 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Zydus Succinylcholine Chloride Injection, USP, 200 mg/10 mL, is recalled after out-of-specification test results for an individual unknown degradation impurity. 270,125 vials are affected.
Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.
Lannett mixed amphetamine salts tablets, 10 mg, lot 25283185A, are recalled because two bottles each contained one 5 mg tablet. 4,848 bottles are affected.
Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.
TiBrid SA Angled Screwdrivers in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.