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.
ELV Control Herbal Supplement is being recalled because it contains yellow oleander instead of the labeled tejocote ingredient. Yellow oleander is toxic to humans. The product was distributed through authorized dealers and e-commerce platforms.
Andersen & Sons Shelling, Inc. is recalling its macadamia nuts due to Listeria monocytogenes contamination. Approximately 2,850 pounds were distributed in the United States.
GLOBAL MIX INC. is recalling Tejocote Root Products sold under multiple brand names because they contain Yellow Oleander, a toxic plant. Consumers should not use these products.
Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.
Philips is recalling 307 SENSE XL TORSO COIL 3.0T units used in MR imaging systems worldwide due to potential for coils to overheat and cause patient burn injuries.
Philips recalled 14 SENSE XL Torso Coils worldwide due to potential overheating. The coils could heat up during use and cause patient burn injuries.
Queso Chonero Special White Cheese has been recalled due to Listeria monocytogenes contamination. The product was distributed in Illinois.
Philips is recalling SENSE XL TORSO COIL units used in MRI imaging because the coils may heat up excessively and cause patient burns. This FDA Class I recall affects 729 units distributed worldwide.
Maquet Cardiovascular recalls VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems due to fluid ingress into the harvesting tool handle, which may prevent necessary cautery or cause unintended cautery during surgical procedures.
GE Healthcare medical monitors may fail to display following a power loss event after CPU battery replacement, potentially delaying patient condition recognition.
Medtronic is recalling 6 units of the MIRRO MRI VR SureScan implantable cardioverter defibrillator due to a potential manufacturing defect. The devices failed manufacturing quality checks because of a weld crack.
NovaGuide 2 Traditional Ultrasound systems may have grounding cables that can be inadvertently disconnected during use, creating risk of electrical shock and equipment malfunction. Twenty-eight systems have been distributed nationwide.
Classic Delight LLC is recalling Wakefield Spicy Hawaiian Sliders due to possible contamination with Listeria monocytogenes. The recalled product was distributed across 14 states.
Classic Delight LLC is recalling 2,311 cases of Wakefield Bacon, Egg & Cheese Bagels (Item 514711) due to possible Listeria monocytogenes contamination. The affected product was distributed across 14 states.
Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.
Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
Penguin Natural Foods is recalling 'THE PERFECT CHOCOLATE CHUNK COOKIE MIX Cravings by Chrissy Teigen' because the product contains undeclared coconut. Consumers with coconut allergies face a serious health risk.
Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.
Medtronic is recalling two PRIMO MRI DR SureScan implantable cardioverter defibrillators due to a potential manufacturing defect involving weld cracks detected during manufacturing quality testing.
Siemens MULTIX TOP I PRO X-ray tables are recalled due to a power supply short circuit that may cause overheating and fire. Three units have been identified.
Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.
Classic Delight Chili Cheese Dogs are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 20,817 cases distributed across 14 states.
Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.
Classic Delight Twin Breaded Chicken Sliders distributed to institutional food service are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 1,767 cases across 14 states.
FEEL GOOD FOODS INC is recalling Cream Cheese Stuffed Plain Mini Bagels due to undeclared gluten. Consumers with gluten sensitivity or celiac disease should not consume this product.