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.
Procedure packs containing Sol-M manufactured syringes are being voluntarily recalled nationwide. The affected product is part number 58000603.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M 1ml syringes distributed nationwide. The syringes contain specific design features that prompted the recall.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall initiated by the syringe manufacturer. 76 units affected 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.
Beaver Visitec International is voluntarily recalling 133 units of BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The Class II recall affects units distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall. The affected packs have been distributed nationwide in the US.
Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.
The FDA is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes under a voluntary recall from the syringe manufacturer affecting nationwide distribution.
Beaver Visitec International is recalling 505 CustomEyes Procedure Packs containing Sol-Millennium Medical syringes that are subject to a voluntary manufacturer recall.
BVI CustomEyes Procedure Packs containing Sol-M syringes are being voluntarily recalled due to a defect in the syringes.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall initiated by the syringe manufacturer. No illnesses or injuries have been reported.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These packs were distributed nationwide.
BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 148 units distributed in the US.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs (Lot 6066752) containing Sol-M syringes. Approximately 22 units distributed nationwide in the US have been affected.
Beaver Visitec International is voluntarily recalling 1,429 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The packs were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical due to a supplier voluntary recall affecting 71 units nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected packs have been distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to a manufacturer's voluntary recall. 388 units were distributed nationwide.
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes following a voluntary recall initiated by syringe manufacturer Sol-Millennium Medical (Sol-M), Inc.
Glenmark Pharmaceuticals recalls 2,404 bottles of Indomethacin Extended-Release Capsules nationwide due to failed dissolution specifications that could affect medication effectiveness.
Beaver Visitec International has recalled 115 units of BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The voluntary recall addresses a manufacturing issue with the syringes included in the procedure packs.
McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.
Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.
Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.