BEUDAMED
    FDA Recall Open, Classified

    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

    Recall: Z-2070-2026 · Initiated March 25, 2026

    Recall

    Recall Number
    Z-2070-2026
    Event Number
    98660
    Firm
    Katalyst Surgical, LLC
    FEI Number
    3007589150
    Product Code
    HNR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2026
    Posted
    May 6, 2026
    Address
    722 Goddard Ave, Chesterfield, MO, 63005-1100

    Description

    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

    Reason

    Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

    Action

    A Field Safety Notification: Field Safety Corrective Action for IFU in DEX Forceps and Scissors dated 3/19/26 was sent to customers. FIELD SAFETY ACTIONS REQUIRED As a customer identified in the receipt of one or more of the affected lots, you are requested/required to take the following steps: 1. Please confirm receipt of this Field Safety Notification by email, either by replying to the sender or using the email addresses listed in the signature at the bottom of this notice. 2. Review the Individualized List of Affected Lot Numbers by Customer provided in the email for lots that were distributed to your facility. Identify all of these lots that currently remain in your stock and place them on hold. 3. Provide information to Katalyst Surgical team identifying which lots are currently in stock and on hold at your facility. Katalyst Surgical will send a replacement correct IFU for each affected box. 4. Upon receipt of the correct IFU, remove the incorrect IFU, replace the correct IFU in the box, and destroy the incorrect IFU. Approval for Modification including instructions will accompany the replacement IFUs. 5. We recommend you reach out to your customers/users of these DEX products with this information. Katalyst Surgical will gladly provide correct replacement IFU documents to you for further distribution. Katalyst Surgical deeply regrets the inconvenience this causes. We assure you of our continuous support and commitment to safety and quality. Please do not hesitate to contact our team if you have any further questions.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

    Quantity

    10 units