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.
SurePulse Medical is recalling the Surepulse VS Cap Extra Small because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.
JUICE from the Raw, spicy lemonade is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
JUICE from the Raw, cashew milk is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
JUICE from the Raw, cashew coffee milk is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
B.C. Williams Bakery Service is recalling 720 bags of Bread and Roll Mix, sold in 50 lb bags, over an undeclared milk allergen.
JUICE from the Raw, sweet greens is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
JUICE from the Raw, pineapple mint is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.
Green Lumber Holdings is recalling Green Lumber Natural Fuel For Men capsules because FDA analysis found the product to contain tadalafil, and it is marketed without an approved application.
Handelnine Global is recalling four bottles of Rheumacare capsules after the product was found to contain lead.
B.C. Williams Bakery Service is recalling 51 bags of Spice Cake Mix, sold in 50 lb bags, over an undeclared milk allergen.
Boston Scientific is recalling 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.
Tai Phat Wholesalers is recalling 10 cases of Sofit Seedless Red Dates, 12 oz, over undeclared sulfites.
JUICE from the Raw, upbeat is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.
Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.
Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.
B.C. Williams Bakery Service is recalling 95 bags of Swiss Chocolate Cake Mix, sold in 50 lb bags, over an undeclared milk allergen.
VH Foods is recalling 4,497 packages of Outside The Breadbox brand Bread Crumbs, 8 oz, over undeclared egg and milk.
Tradin Organics USA is recalling 54,680 lbs of Organic Chia Seed Black over potential contamination with Salmonella.
JUICE from the Raw, Detox Greens is being recalled by Everpress Juice because the under-processed product may contain pathogenic bacteria that could harm humans.