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.
Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.
Reisman's Chocolate Babka Slices 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Reisman's Cappuccino Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Reisman's Vanilla Wrap 3 oz is being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.
SwabFlush Prefilled Syringes with ICU Medical SwabCaps are being recalled because a manufacturing issue affects the SwabCap seal, which may reduce disinfection of the luer access valve. 1,427,100 units affected.
Ingenia Elition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 632 units are affected.
Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.
Ingenia 1.5T S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 136 units are affected.
Osteotec Silicone Finger Implants in sizes 3, 4 and 5 are being recalled because there is the potential that the silicone implant may contain foreign material. 15,573 units are affected.
Fresh Chilean Salmon Fillets sold in 50 lb boxes are being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture.
Reisman's Fudge Bars 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.
Dual Flat Panel Monitor accessories for HarmonyAIR E-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 59 units are affected.
Reisman's Candy Blast Brownie Snack 3 oz is being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.
Evolution Upgrade 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 50 units are affected.
NH European Style Butter Blend from Bunge, 1 lb blocks, is being recalled because of undeclared milk. 64,800 pounds across 1,800 cases are affected.
Reisman's Cinnamon Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Yellow Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 68.10 lb affected.
Blue Fin Tuna sold in 50 lb boxes is being recalled because ready-to-eat fish was processed under insanitary conditions, as notified by the Georgia Department of Agriculture. 59 lb affected.
SmartPath to dStream for XR and 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 294 units affected.
Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.
A lot of RAPIDPoint 500 Systems Wash/Waste Cartridges is being recalled because a manufacturing error causes positive and negative bias across seven analytes. 1,477 units are affected.
Ingenia Ambition X MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 690 units are affected.
Reisman's Chocolate Wrap 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.