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.
Chuao Chocolatier is voluntarily recalling mini chocolate bars (LOT 4022, Best by 22 FEB 25) due to undeclared hazelnut. The 13,312-bar recall affects distribution broadly across the U.S. and four international locations.
The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.
Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.
MEDLINE is recalling 700 non-sterile 10ML syringes because their piston sizes and configurations exceed the range approved by FDA. No illnesses have been reported. Consumers should stop using these syringes.
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.
Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
DANONE US LLC is recalling YoCrunch Vanilla Lowfat Yogurt with M&Ms due to undeclared wheat. The product was distributed to one consignee in Florida and poses a risk to consumers with wheat allergies.
Philips is recalling 2,262 Ingenia 1.5T MRI systems worldwide because a loose terminal connection in the power distribution unit can overheat and cause fire or smoke.
Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.
Marketside Brioche Rolls may contain undeclared soy lecithin, posing a risk to consumers with soy allergies. Consumers should not eat this product if they have a soy allergy.
Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.
Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.
Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.
Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.
Philips Ingenia Elition X- MRI systems have a loose terminal connection in the power distribution unit that may create a hotspot and cause smoke or fire in hospital settings. No injuries have been reported.
Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses have been reported.
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.