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.
Cal Yee's Dark Chocolate Almonds contain undeclared milk and are being recalled. The product was distributed at 2 California retail stores and online in California and Pennsylvania.
Cal Yee's Yogurt Coated Almonds recalled for undeclared milk. Voluntary recall covers products distributed to retail stores and online/phone orders in California and Pennsylvania.
Cal Yee Farm LLC is recalling Tropical Trail Mix due to undeclared milk, a common allergen. The product was sold at 2 California retail stores and via online/phone orders in California and Pennsylvania.
Cal Yee Farm LLC is recalling Cal Yee's Cajun Sesame Hot Sticks (1-lb bags) due to undeclared wheat and soybean oil. The product was sold in California retail stores and through online/phone orders in California and Pennsylvania.
Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.
Horizon Organic Aseptic Plain Whole Milk may spoil before its expiration date. The recalled products were distributed in Arizona, California, and Nevada.
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
Cal Yee Farm LLC recalls Butter Toffee Almonds for undeclared milk. Products affected: Cal Yee's (8-oz, 1-lb bags) and Boa Vista (6-oz bag). Distribution: 2 California retail stores and online/phone orders to California and Pennsylvania.
BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.
Jinan Bodor Cnc Machine Co Ltd is recalling 269 units of Bodor P and C series laser cutting machines distributed nationwide due to non-compliance with FDA standards.
Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.
Cal Yee Farms Fruit Basket (50-oz) is being recalled due to undeclared almonds. The product was distributed to 2 retail stores in California and through online and phone orders to California and Pennsylvania.
Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
The Granola Bar's OG Bar granola bars are being recalled due to undeclared milk and soy allergens. People with allergies to these ingredients should not consume this product.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.
St. Jude Medical is recalling the CardioMEMS HF Pressure Measurement System due to a cloud data migration that caused the system to revert to an outdated configuration, resulting in inaccurate pulmonary artery pressure readings.
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.