BEUDAMED
    FDA Enforcement Class II Ongoing

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

    Recall: Z-2072-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2072-2026
    Event ID
    98660
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Katalyst Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    March 25, 2026
    Classification Date
    May 6, 2026
    Address
    722 Goddard Ave, Chesterfield, MO, 63005-1100, United States

    Description

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

    Reason

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

    Code Info

    Lot Code: Model No:DVF4016-25-S UDI-DI: (01)10840096205128(11)250709(17)280709(10)M48801 Lot Number: M48801 Expiration Date: 07/09/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251010(17)281010(10)M49278 Lot Number: M49278 Expiration Date: 10/10/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250429(17)280429(10)M47582 Lot Number: M47582 Expiration Date: 04/29/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250527(17)280527(10)M48049 Lot Number: M48049 Expiration Date: 05/27/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251125(17)281125(10)M51038 Lot Number: M451038 Expiration Date: 11/25/2028

    Distribution

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

    Quantity

    90 units