The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

551–575 of 3531

  • ModerateFDA (Devices)·Z-2822-2024·2024-09-04

    BVI CustomEyes Procedure Pack Syringes Voluntarily Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. due to a voluntary manufacturer recall of certain syringe types distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
    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-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-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-2781-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. due to a manufacturer's voluntary recall. 659 units are affected nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2832-2024·2024-09-04

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

    BVI voluntarily recalls CustomEyes Procedure Packs because they contain syringes recalled by their manufacturer, Sol-Millennium Medical, Inc. Approximately 94 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;
    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-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-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-2910-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2790-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Voluntarily

    BVI CustomEyes Procedure Packs containing low dead space and luer slip syringes from Sol-Millennium Medical are being voluntarily recalled.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584727;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2892-2024·2024-09-04

    BVI CustomEyes Procedure Packs With Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 478 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
    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-2868-2024·2024-09-04

    BVI CustomEyes Procedure Packs With Recalled Sol-M Syringes

    BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. The affected products are distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2821-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. The recall affects 840 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2938-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for Sol-M syringe components

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes with low dead space and luer slip tip configurations. The product was distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;
    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 (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-2855-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

    BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2929-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs that contain Sol-Millennium Medical syringes following a concurrent recall of those syringes. The packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001967;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2906-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) syringes, affecting 126 units distributed nationwide. The recall was initiated following a manufacturer recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2893-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes due to a voluntary recall by the syringe manufacturer. The recall affects 170 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2931-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2909-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2861-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The recall affects 876 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;
    Category
    Medical Device
    Distribution
    Distributed nationwide