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.
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.
FGF, LLC is recalling Just Baked Apple Fritters nationwide due to potential Listeria monocytogenes contamination. Consumers should discard affected products.
FGF cake sticks are being recalled nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not eat the product and should return it to retailers.
FGF, LLC is recalling Bavarian Paczki (item 8201814) due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.
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 Persian Donut item 8201808 nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard it or return it to the retailer.
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.
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.
FGF, LLC recalls approximately 2,017,614 cases of Just Baked Cake Rings distributed nationwide due to potential contamination with Listeria monocytogenes.
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.
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.
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.
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.
Hologic Rapid fFN Specimen Collection Tubes from three lots may contain incorrect amounts of extraction buffer, potentially causing invalid test results or diagnostic errors in preterm delivery assessment.
FGF, LLC is recalling Just Baked Blueberry Cake Ring products for potential Listeria monocytogenes contamination. Approximately 2.0 million cases distributed nationwide to the US and Canada with production dates on or before December 13, 2024.
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 recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.
FGF LLC is recalling apple fritters nationwide due to potential Listeria monocytogenes contamination. All product produced on or before December 13, 2024 is affected.
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.
Glenmark Pharmaceuticals is recalling carvedilol tablets nationwide due to N-nitroso carvedilol I (NNCI-I), a carcinogenic impurity found in certain lots. The impurity exceeds FDA safety limits.
FGF LLC is recalling 2,017,614 cases of Just Baked Coffee Rolls (78 x 3oz packages) due to potential Listeria monocytogenes contamination. The affected product was produced on or before 12/13/24 and distributed nationwide in the US and Canada.
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
FGF's Just Baked Sour Cream Cake Donuts are being recalled nationwide due to potential Listeria monocytogenes contamination. Approximately 2 million cases produced on or before December 13, 2024 are affected.
414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.
FGF, LLC is recalling Just Baked Pumpkin Cake Munchkins nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.