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.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No illnesses or injuries have been reported.
Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes distributed nationwide.
Beaver Visitec International (BVI) is recalling CustomEyes Procedure Packs because they contain Sol-Millennium Medical (Sol-M) syringes that Sol-M has voluntarily recalled.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being recalled in a voluntary action. 207 units with Part Number 58001999 are distributed nationwide.
RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices due to missing design and development documentation. Devices may not perform as intended.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical. The FDA has classified this as a Class II medical device recall.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes as a voluntary Class II recall. The recall affects 103 units distributed nationwide.
Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide containing syringes from Sol-Millennium Medical's voluntary recall.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., subject to a voluntary recall by the manufacturer.
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) low dead space and luer slip tip 1ml syringes are being recalled due to a voluntary recall of these syringes.
Beaver Visitec International is voluntarily recalling 216 units of BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-M. The recall affects nationwide distribution.
BVI is recalling CustomEyes Procedure Packs containing syringes from Sol-Millennium Medical due to Sol-M's voluntary recall of those syringes.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical due to a voluntary recall by the syringe manufacturer.
Beaver Visitec International is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall by the syringe manufacturer, Sol-Millennium Medical, Inc.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 58001554) due to manufacturing concerns with the syringe components.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these components.
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall. The recall affects 9 units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall by the manufacturer. The procedure packs were distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected procedure packs contain low dead space Luer Lock and Luer Slip 1ml syringes distributed nationwide.
Beaver Visitec International voluntarily recalls specific CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No injuries or illnesses have been reported.
BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. The recall involves 315 units distributed nationwide.
Beaver Visitec International recalled BVI CustomEyes Procedure Packs containing defective 1ml syringes manufactured by Sol-Millennium Medical. The 68-unit recall involves procedure packs distributed nationwide in the United States.
BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. Users of affected packs should discontinue use and contact the manufacturer.
The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 8 units have been distributed nationwide.