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.
Danisco USA Inc. is recalling Grindsted GSD 1076 Stabilizer and Emulsifier System in 50-pound bags due to potential Salmonella contamination. The product was distributed to multiple US states, Canada, and Mexico.
Danisco USA Inc. recalls Grindsted Sour Cream 6563 stabilizer system for potential Salmonella contamination affecting 33,600 kg distributed across the US, Canada, and Mexico.
Danisco USA Inc. recalls CRE-90 (RO1) 25 KG bags due to potential Salmonella contamination. The product was distributed across 24 U.S. states, Canada, and Mexico.
The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.
Danisco USA Inc. is recalling Grindsted Iced Coffee 6752 Stabilizer System in 50 lb bags due to potential Salmonella contamination. The recall affects product distributed across the US, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Sweet Roll Dough Blend 2 Stabilizer & Emulsifier System due to potential Salmonella contamination. The product was distributed across the US, Canada, and Mexico.
Danisco USA Inc. is recalling CRE-90 (RO1) Stabilizer System due to potential Salmonella contamination. The product was distributed across multiple US states, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted TH GSD 2272 Stabilizer and Emulsifier System distributed in bulk due to potential Salmonella contamination. The product was distributed across the U.S., Canada, and Mexico.
Arrow International is recalling its UltraFlex Intra-Aortic Balloon Catheter Kit because of infrequent device malfunction that could lead to serious health consequences. 44,807 units are affected worldwide.
Danisco USA Inc. is recalling Germantown Dari Whip II, a food stabilizer and emulsifier product, due to potential Salmonella contamination. The product was distributed across 23 US states, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Whipped Cream #2 stabilizer system due to potential Salmonella contamination. The product was distributed in 24 US states, Canada, and Mexico.
Atrium Medical recalls FLIXENE vascular grafts due to reported separation of the Swivel Rod from the Swivel Core, creating gaps that could affect device function. Over 53,000 units worldwide are affected.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect device function.
Stryker Neurovascular is recalling certain lots of Synchro Neuro Guidewires due to PTFE coating damage that can occur when using a backloading technique with the optional introducer. Clinicians should avoid the backloading technique with affected product.
FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.
ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.
Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.
Charles Boggini Company is recalling Cola Flavoring Base due to undeclared sulfites. The product may trigger allergic reactions in sulfite-sensitive individuals.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units have been affected worldwide.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.
Verathon is recalling GlideScope Core 15-inch monitors due to software issues causing potential image loss or degradation. Approximately 2,568 units were distributed across the US and internationally.
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units affected worldwide.
ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core. The separation could affect device function during vascular procedures.
Simultaneous ECG measurements with multiple devices can cause electrical interference that may prevent this defibrillator from functioning properly. The recall affects 1,745 units distributed nationwide.