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 over 2 million cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
Teva Pharmaceuticals is recalling Granix injection due to failed stability test results showing one peptide did not meet specification limits.
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.
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.
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.
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.
Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.
FGF, LLC is recalling 2,017,614 cases of frozen donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.
Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.
FGF, LLC is recalling JUST BAKED FRENCH CRULLERS nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.
FGF, LLC is recalling apple-filled paczki sold nationwide due to potential contamination with Listeria monocytogenes. Affected units were produced on or before December 13, 2024.
FGF, LLC is recalling item 8201810 Fluff Bars distributed nationwide to the US and Canada due to potential Listeria monocytogenes contamination. No illnesses have been reported.
FGF, LLC is recalling 2,017,614 cases of JUST BAKED Chocolate Cake Rings distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.
FGF, LLC is recalling French Crullers (item 8201921) distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.
Philips Azurion 7 M20 and Allura patient tables pose a finger entrapment risk during manual repositioning. Fingers can get caught between the tabletop and guiding rails, potentially causing finger injury to operators and service personnel.
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
Philips Azurion 5 M20 x-ray system patient tables can trap fingers between the tabletop and guiding rails during repositioning. The hazard may cause finger injury to operators and service personnel.
Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.
GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.