The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

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.

11601–11625 of 88183

  • ModerateFDA (Devices)·Z-2918-2024·2024-09-04

    CustomEyes Procedure Packs with Sol-M Syringes Recalled by Beaver Visitec International

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2805-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing recalled Sol-M syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000305;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2865-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001380;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2831-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000873;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2903-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling 44 units of BVI CustomEyes Procedure Packs because they contain syringes from Sol-Millennium Medical, which are subject to a separate voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for Sol-M syringe defects

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001608;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2854-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Syringes Recalled Nationwide

    BVI CustomEyes Procedure Packs containing Sol-M syringes are being voluntarily recalled due to a defect in the syringes.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001304;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2926-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2845-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Design

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001118;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2863-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled by the FDA. The affected 1ml Luer Lock and Luer Slip syringes were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001375;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2871-2024·2024-09-04

    FDA Recalls BVI CustomEyes Procedure Pack Syringes from Sol-M

    The FDA is recalling BVI CustomEyes Procedure Packs due to a voluntary recall by Sol-M of syringes within them. The affected product (Part Number 58001423, Lot 6062969) was distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2934-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2818-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Component

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000709;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2024·2024-09-04

    Beaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2933-2024·2024-09-04

    FDA recalls Sol-M syringes in BVI CustomEyes Procedure Packs

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2856-2024·2024-09-04

    BVI CustomEyes Procedure Packs With Sol-M Syringes Voluntarily Recalled

    Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs (Part Number 58001306, Lot 6072093) containing Sol-M manufactured syringes. The recall affects 206 units distributed nationwide due to a voluntary recall by the syringe manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001306;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2783-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 584545) nationwide. The recall is voluntary.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2791-2024·2024-09-04

    FDA Recalls BVI CustomEyes Procedure Packs with Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2887-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2852-2024·2024-09-04

    Medical Device Syringe Recall: BVI CustomEyes Procedure Packs

    BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 148 units distributed in the US.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001200;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide due to the inclusion of syringes manufactured by Sol-Millennium Medical that are subject to a voluntary manufacturer recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Nationwide for Syringe Defects

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2850-2024·2024-09-04

    Medical Syringes in BVI CustomEyes Procedure Packs Recalled

    BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. The recall involves 315 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001176;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes

    Beaver Visitec International is recalling 214 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;
    Category
    Medical Device
    Distribution
    Distributed nationwide