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 A60647 bread crumbs in 35 lb units are being recalled because of potential Listeria monocytogenes contamination. 37,765 lbs are affected.
Newly Weds B6010J bread crumbs in 35 lb units are being recalled because of potential Listeria monocytogenes contamination. 41,650 lbs are affected.
Sheehan Brothers Vending Pepperoni Pizza Mini Subs, 4.8 oz, are being recalled because of undeclared sesame. 614 individual units are affected.
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
Sheehan Brothers Vending Cheeseburgers, 4.7 oz, are being recalled because of undeclared sesame. 824 individual units are affected.
Newly Weds E54564 Breader X5 in 25 lb units is being recalled because of potential Listeria monocytogenes contamination. 42,500 lbs are affected.
Newly Weds B61672 bread crumbs in 35 lb units are being recalled because of potential Listeria monocytogenes contamination. 7,000 lbs are affected.
Sheehan Brothers Vending BBQ Riblet Sandwich with Coleslaw, 8 oz, is being recalled because of undeclared sesame. 209 individual units are affected.
Newly Weds B6229J Pizza Crisp in 35 lb units is being recalled because of potential Listeria monocytogenes contamination. 3,500 lbs are affected.
Newly Weds bread crumbs in 35 lb units are being recalled because of potential Listeria monocytogenes contamination. 33,250 lbs are affected.
Newly Weds B6047J bread crumbs in 35 lb units are being recalled because of potential Listeria monocytogenes contamination. 15,750 lbs are affected.
Newly Weds B61610 bread crumbs in 45 lb units are being recalled because of potential Listeria monocytogenes contamination. 5,625 lbs are affected.
Newly Weds B57569 breader in 25 lb units is being recalled because of potential Listeria monocytogenes contamination. 1,250 lbs are affected.
Lespoir cookies, net weight 1.41 oz, are being recalled because of undeclared milk. 32 units are affected.
Achieva 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. 460 units are affected.
MR 5300 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. 551 units are affected.
Reisman's Jumbo Pink & White Cookies 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.
Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.
Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.
Reisman's Chocolate Danishes 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.
LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.
Reisman's Cinnamon Croissants 3 oz are being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.
Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.