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 166 units of the MR 5300 Magnetic Resonance System worldwide because the patient support table floor plate may be incorrectly installed on affected units.
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
Canadian Art Prints is recalling Tranquility & Teachings plate sets that may exceed FDA guidance levels for leachable lead. The recall affects 83 boxes distributed across 14 U.S. states.
Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.
Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.
Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.
Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.
Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.
Baxter Healthcare Corporation recalled marketing brochures for surgical tools that contain inaccurate information conflicting with the product Instructions for Use. Over 82,000 units were distributed worldwide.
Smith & Nephew is recalling RENASYS EDGE 300ML canisters due to black particulate matter from the carbon filter that may enter the pump. The recall affects 6,895 units distributed in the US, Canada, and Chile.
Abdallah Candies is recalling Sea Salt Almond Alligators due to incorrect back label showing chocolate covered cherries information instead of the actual product.
Aromitalia Malasia Coconut Paste is being recalled because coconut is listed in the ingredients but not declared in the contains statement, potentially affecting consumers with coconut allergies.
Windsor Black Peppercorns are mislabeled. Products labeled as black peppercorn actually contain Pink Himalayan salt. Affected lot code ZX23060001, distributed in Canada.
Esperion is recalling certain NEXLIZET (bempedoic acid and ezetimibe) tablets nationwide because the active ingredient may not dissolve properly, potentially reducing effectiveness.
Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.
Robeson Enterprises is recalling Mo' Money Pie due to undeclared soy allergen on the label. The product was distributed to Georgia, North Carolina, and South Carolina.
Robeson Enterprises recalls PIES & SIDES brand pumpkin pie because the product label fails to list undeclared milk and eggs, posing a risk to consumers with these allergies.
Eugia US LLC is recalling Methocarbamol Injection nationwide due to particulate matter contamination. The FDA classified this as a Class I recall affecting lot 3MC23011 (expiration 11/30/2026).
Robeson Enterprises is recalling 482 units of PIES & SIDES Baked Mac and Cheese because the label fails to declare egg as an allergen and does not list any ingredients. Products were distributed to Georgia, North Carolina, and South Carolina.
Naturz Organics is recalling Organic Pea Protein (Item Code NO-OPP-80, 20 kg bags) due to possible salmonella contamination. The recall affects bulk product distributed to one consignee in Wisconsin.
Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.
Alipotec Raiz de Tejocote dietary supplements are being recalled because they contain toxic yellow oleander instead of tejocote. All 280 bottles were distributed nationwide.