BEUDAMED
    FDA Enforcement Class II Ongoing

    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

    Recall: Z-2071-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2071-2026
    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 Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S

    Reason

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

    Code Info

    Lot Code: Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250909(17)280909(10)M49277 Lot Number: M49277 Expiration Date: 09/09/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250513(17)280513(10)M47588, Lot Number: M47588 Expiration Date: 05/13/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47364, Lot Number: M47364 Expiration Date: 05/06/2028 Model No: DVF4014-25-S UDI-DI: (01)10840096205111(11)250506(17)280506(10)M47363 Lot Number: M47363 Expiration Date: 05/06/2028

    Distribution

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

    Quantity

    80 units