BEUDAMED
    FDA Enforcement Class II Ongoing

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

    Recall: Z-2079-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2079-2026
    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 Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

    Reason

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

    Code Info

    Lot Code: Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)250429(17)280429(10)M47337 Lot Number: M47337 Expiration Date: 04/29/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251023(17)281023(10)M50921 Lot Number: M50921 Expiration Date: 10/23/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251209(17)281209(10)M51525 Lot Number: M51525 Expiration Date: 12/09/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)251209(17)281209(10)M51526 Lot Number: M51526 Expiration Date: 12/09/2028 Model No: DVF4034-25-S UDI-DI: (01)10840096205166(11)260220(17)290220(10)M52172 Lot Number: M52172 Expiration Date: 02/20/2029

    Distribution

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

    Quantity

    50 units