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.
Ingenia 1.5T 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. 2,279 units are affected.
Reisman's Chocolate Snack 3 oz is being recalled because of undeclared wheat and soy. The action covers 186,582 units across all recalled Reisman's products.
Reisman's Strawberry Bars 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.
Achieva XR 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. 40 units are affected.
MR 7700 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. 82 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.
SmartPath to dStream for 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. 15 units affected.
Reisman's Chocolate Croissants 3 oz are being recalled because of undeclared wheat. The action covers 186,582 units across all recalled Reisman's products.
Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.
Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.
LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Apic Yamada WCM series molding equipment, model WCM-330GL-i, is being recalled because certain products may be out of compliance with FDA electronic product regulations for not bearing a required label. 6 units affected.
Suspiros Cheese Cake Coyota is being recalled because it contains goat milk, which was labeled simply as "milk". 27 units are affected.
Cinacalcet Tablets 90 mg from Strides Pharma are being recalled because they failed dissolution specifications. 6,672 bottles are affected.
Suspiros Mazapan Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 127 units are affected.
Sprinter Cart and Sprinter Cart XL Infusion Poles are being recalled because the device does not comply with the labeling requirements of international standard IEC 60601-1. 7,754 units affected.
The 3M Ranger Irrigation Fluid Warming Set is subject to a notice issued to clarify flow rates related to the inlet fluid temperature. 186,880 units are affected.
Suspiros Chocoflan Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 82 units are affected.
LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.
Organic Pure Stevia, 1 oz, is being recalled because the product is monk fruit powder but the bottle was mislabeled as Organic Pure Stevia. 78 bottles are affected.
IontoPatch 80 On-the-Go Patch Therapy is being recalled because the nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with it. 63,936 units affected.
Suspiros Cajeta Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 268 units are affected.
Suspiros Choconut Cake is being recalled because it contains goat milk, which was labeled simply as "milk". 124 units are affected.
BostonSight SCLERAL Lenses are being recalled because select orders were manufactured with errors impacting sagittal height, haptics, or both. 441 units are affected.
Cajeta cupcakes and other cake products are being recalled because they contain goat milk, which was labeled simply as "milk". 24 units are affected.