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.
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled nationwide.
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 voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. Approximately 70 units have been distributed nationwide.
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 recalls BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The specific reason for the recall is not detailed in the FDA notice.
Beaver Visitec International initiated a voluntary recall of BVI CustomEyes Procedure Packs containing surgical syringes (Part Number 584550, Lot 6048601) distributed nationwide. The Class II recall was initiated on July 26, 2024.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. The recall affects 489 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 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 due to a voluntary manufacturer recall of those components.
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected syringes are low dead space and luer slip tip models distributed nationwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes with low dead space and luer slip tip configurations. The product was distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, which are subject to a voluntary recall. 37 units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate voluntary 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 is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.
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 voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip syringes. The recall affects 150 units distributed nationwide.
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected units were distributed nationwide.
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.
The FDA is issuing a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes affecting 1,029 units distributed nationwide.
BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary manufacturer recall. The affected packs were distributed nationwide in the U.S.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 196 units distributed nationwide.