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.

9726–9750 of 27089

  • ModerateFDA (Devices)·Z-2784-2024·2024-09-04

    FDA recalls BVI CustomEyes ophthalmic procedure packs nationwide

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
    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-2815-2024·2024-09-04

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

    Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000594, Lot 6073112) containing Sol-M manufactured 1 milliliter syringes due to a recall of those syringes by their manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2846-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International is recalling 1,238 units of BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall is voluntary and affects procedure packs distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001123;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2912-2024·2024-09-04

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

    Beaver Visitec recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes subject to manufacturing defect concerns. 17 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;
    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-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-2921-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Components

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. Approximately 79 units were distributed nationwide with no reported injuries.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001865;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2786-2024·2024-09-04

    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 procedure packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584625;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2024·2024-09-04

    Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs nationwide because they contain low dead space and luer slip syringes manufactured by Sol-Millennium Medical that are subject to a voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2788-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Component Syringe Issue

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to recall. The affected packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584643;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2833-2024·2024-09-04

    FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes

    The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 8 units have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2825-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes that are subject to a voluntary manufacturer recall. Approximately 260 units are affected nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;
    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-2935-2024·2024-09-04

    Beaver Visitec recalls CustomEyes Procedure Packs containing Sol-Millennium syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs nationwide that contain syringes manufactured by 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: 58002063;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2817-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for Sol-M manufactured syringe component

    Beaver Visitec International voluntarily recalls 2,117 BVI CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The syringes are part of a voluntary recall initiated by the syringe manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000628;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2024·2024-09-04

    Cefixime oral suspension antibiotic recalled nationwide for subpotency

    Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2884-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001554;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2834-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing defective Sol-M syringes. The voluntary recall affects products distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2867-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001394;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2024·2024-09-04

    BrainFeedback Pro 2 neurofeedback device recalled for missing design documentation

    RONAN MEDICAL LLC is recalling BrainFeedback Pro 2 neurofeedback devices due to missing design and development documentation. Devices may not perform as intended.

    Product
    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2809-2024·2024-09-04

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

    BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 45 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;
    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-2896-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

    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.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2785-2024·2024-09-04

    BVI Voluntarily Recalls CustomEyes Procedure Packs Containing Sol-M Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The affected products were distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584587;
    Category
    Medical Device
    Distribution
    Distributed nationwide