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.
FGF, LLC is recalling chocolate-coated donut rings nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected. No illnesses have been reported.
FGF, LLC is recalling Just Baked Apple Cider Cake Rings due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed nationwide in the US and Canada.
The Philips AD7 and AD7X patient tables pose a finger entrapment risk during manual repositioning. Operators and service personnel could sustain finger injuries from the gap between the longitudinal guiding rails and tabletop.
Monkey Spit 'Swamp Mop' BBQ Sauce is being recalled because it contains an undeclared soy allergen in a sub-ingredient. The product was distributed through local markets and online sales nationwide.
FGF, LLC is recalling apple fritter donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Affected products were produced on or before December 13, 2024.
GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.
Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
FGF, LLC is recalling cheese paczki products nationwide due to potential contamination with listeria monocytogenes. Affected products were produced on or before December 13, 2024.
FGF, LLC is recalling 2,017,614 cases of plain cake donuts distributed nationwide in the US and Canada due to potential contamination with Listeria monocytogenes. No illnesses have been reported.
FGF LLC is recalling Bavarian Bismark pastry item 8201936 due to potential listeria monocytogenes contamination. The recall covers all product within expiration produced on or before December 13, 2024, distributed nationwide in the US and Canada.
Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.
Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing finger injury to operators and service personnel.
FGF, LLC is recalling BAV CRM BISMARK DONUT frozen donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the product.
FGF, LLC is recalling 2,017,614 cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.
FGF, LLC has recalled Just Baked Yeast Ring products due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed nationwide in the United States and Canada.
FGF, LLC is recalling flavored raspberry Bismark pastries over potential contamination with Listeria monocytogenes. The recall affects product produced on or before December 13, 2024.
Monkey Spit Atomic Mop BBQ Sauce contains undeclared milk from butter, posing a risk to consumers with milk allergies. Affected bottles were distributed primarily to local markets and nationwide through online sales.
FGF, LLC is recalling Bavarian Filled Donuts distributed nationwide due to potential listeria monocytogenes contamination. Consumers should not consume this product.
RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets because testing found N-nitroso Carvedilol Impurity-1 exceeding FDA's acceptable limit due to manufacturing process deviations.
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
ESL Cinnamon Fries (item 8201871) produced on December 13, 2024 and prior are being recalled due to potential contamination with Listeria monocytogenes. Approximately 2 million cases were distributed nationwide in the US and Canada.
FGF, LLC is recalling yeast donuts nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.