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's Just Baked Pumpkin Cake Rings are being recalled due to potential listeria monocytogenes contamination. Consumers should discard the product or return it to the point of purchase.
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.
FGF, LLC is recalling 2,017,614 cases of item 8201870 Fluff Donuts due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.
FGF, LLC is recalling 2,017,614 cases of Naturally and Artificially Flavored Raspberry Paczki nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.
Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.
Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.
Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.
FGF, LLC is recalling 2,017,614 cases of vanilla mini cake donut rings due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.
The Philips AlluraXper FD20 operating room table can trap fingers between the guiding rails and tabletop during manual repositioning, potentially injuring operators and service personnel.
FGF, LLC is recalling Persian yeast donuts due to potential Listeria monocytogenes contamination. The recall affects all product produced on or before December 13, 2024.
The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.
FGF, LLC is recalling Just Baked Eclairs nationwide in the US and Canada due to potential Listeria monocytogenes contamination. All products produced on 12/13/24 or earlier are affected.
FGF, LLC is recalling JUST BAKED Yeast Munchkins nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.
FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Consumers should not consume the product and should discard or return it.
FGF, LLC is recalling over 2 million cases of unfilled Bismarck donuts due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the US and Canada.
FGF's Twist Donuts are being recalled nationwide in the US and Canada due to potential Listeria monocytogenes contamination. The recall affects approximately 2 million cases produced on or before December 13, 2024.
Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.
Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.
Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.
SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.
Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.
Monkey Spit Monkey Mop BBQ Sauce is recalled because it contains undeclared milk from butter, a common allergen. Consumers with milk allergies should not consume this product.
FGF, LLC recalls Apple Crisp Cake Donuts for potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected.
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.
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.