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.
Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel in 1.41 oz and 8 oz packages due to undeclared sub-ingredients in the sunflower butter component. Consumers should not consume the affected product.
Medline is recalling 1,770 Peripheral Blood Culture Draw kits because components within the kits have expired before the kit's stated expiration date.
Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.
Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.
Amazon Fresh Frosted Mini Brownies (Item 19858) may contain plastic pieces. The 12-count packs distributed nationwide are subject to recall.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because the sub-ingredients of sunflower butter were not declared on the label. The affected packages were distributed in Iowa and Illinois.
Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because sunflower butter sub-ingredients were not declared on the label. Consumers with sunflower allergies may experience allergic reactions.
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.
Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.
ORALE! CAMARON NATURAL shrimp in 2 oz. packages (Lot F-219) is recalled due to undeclared Red #40 food coloring. Approximately 7,584 units were distributed domestically.
EL CHILAR natural shrimp (2 oz packages, Lot F-219) recalled due to undeclared Red #40 food coloring. The product was voluntarily withdrawn from domestic distribution.
Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sub-ingredients in the sunflower butter component. The products were distributed in Iowa and Illinois.
Blum's Shrimp Shred dried shrimp is recalled due to undeclared Red #40 food coloring. Affected lot 230828 was distributed domestically in the United States.
ORALE! CAMARON MOLIDO ground shrimp (Lot F-219) is recalled due to undeclared Red #40 food coloring. No illnesses have been reported.
Little Bear Fresh Kale from Safeway Fresh Foods LLC is being recalled due to possible Listeria monocytogenes contamination. The recall affects 191 cases distributed in Texas.
Gills Onions is recalling fresh diced yellow onions due to potential Salmonella Thompson contamination. Approximately 16,400 pounds of product was distributed across multiple U.S. states and Canadian provinces.