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.
Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.
Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.
Wegmans Penne Rigate Mozzarella Salad is being recalled due to undeclared milk allergen. Affected products were distributed to stores in New York, Pennsylvania, and Massachusetts.
Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
Julian's Recipe CAULI-WAFEL SANDWICHES with turkey sausage and cheddar are being recalled because they contain undeclared soy lecithin, which poses a risk to people with soy allergies. The recall affects 1,786 cases distributed in New Jersey, New York, Florida, and Pennsylvania.
Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
enterade Advanced Oncology Formula is recalled due to potential mold development and spoilage. The recall affects 43,336 bottles distributed nationwide.
Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.
Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.
Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.
Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom capsules because they contain kratom, an unapproved food additive. Approximately 31,600 pouches were distributed in the United States.
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.
Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.
Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.
Julian's Recipe Maple & Brown Butter Cauli-Wafels are being recalled due to undeclared soy lecithin. The product poses a risk to consumers with soy allergies.
Nutricia North America is recalling TYR Anamix Early Years infant formula due to undeclared tyrosine. The recall affects 94 cans distributed to 22 states and Puerto Rico.
Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.
Julian's Recipe Original Cauli-Wafels are recalled due to undeclared soy lecithin. Consumers with soy allergies face risk of allergic reaction.
FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.