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 53 Allura Xper CV20 interventional X-ray systems because the BIOS battery may deplete faster than designed, preventing the system from starting.
BD is recalling 1,725 Venclose digiRF generators running software 3.35 because the catheter verification check produces false positive failures on properly functioning catheters.
Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.
Philips is recalling 313 Cardio Vascular-Allura Centron systems because the BIOS battery may deplete faster than designed, halting start-up with no warning message.
LeMaitre Vascular is recalling 28 Artegraft Collagen Vascular Grafts because the bovine carotid arteries used to make them came from a supplier not reviewed and approved by the appropriate regulatory authority.
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.
Philips is recalling Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.
Aesculap is recalling one ELAN 4 Fixed Duraguard unit after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.
Toasted Almond & Cherry Biscotti is being recalled because the colour additive Red 40 is not declared on the label. The recall covers 172 cases.
NAFCO is recalling 141 cases of frozen whiting fillets because the retail bags carry a best-by date of 1-11-2025, implying the product is expired when it is good until 1-11-2027.
Middlefield Original Cheese Co-op Monterey Jack and Provolone 5 lb loaves with a sell-by date of 2/13/2026 are recalled for potential Listeria monocytogenes contamination. 7,455 lbs are affected.
Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.
Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lb bags with a sell-by date of 9/3/2025, is recalled for potential Listeria monocytogenes contamination. 7,455 lbs are affected.
Middlefield Original Cheese Co-op Original Swiss Cheese, in 5 lb loaves and 2 lb deli bags with a sell-by date of 2/13/2026, is recalled for potential Listeria monocytogenes contamination.
Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb bags with a sell-by date of 9/3/2025, is recalled for potential Listeria monocytogenes contamination.
GOODLES is recalling 61,176 cartons of Here Comes Truffle creamy truffle flavored cheddar and shells because the product contains cashews that are not declared on the label.
GOODLES Vegan Is Believin' Plant-Based White Cheddar with Spirals, 5.25 oz, is recalled for undeclared milk. The FDA classified the action as Class I. 129,660 cartons are affected.
Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz, with a sell-by date of 2/13/2026, is recalled for potential Listeria monocytogenes contamination.
Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, in 5 lb loaves and 2 lb deli bags, is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I.
Skin MD by Dr Monika Kiripolsky Body Acne Cleanser (Benzoyl Peroxide 10%, 7 oz) is being recalled due to elevated levels of benzene discovered during post-market monitoring. Affected lots 58170A and 58172A with expiration date 09/2025 were distributed in California and Georgia.
Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.
Middlefield Original Cheese Cooperative is recalling Smoked Cheddar 5 lb. loaves due to potential Listeria monocytogenes contamination. The recall affects products packed on August 14, 2025, distributed across OH, PA, WI, and TX.