BEUDAMED
    FDA Enforcement Class II Ongoing

    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

    Recall: Z-2073-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2073-2026
    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, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

    Reason

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

    Code Info

    Lot Code: Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250807(17)280807(10)M49267 Lot Number: M49267 Expiration Date: 08/07/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251017(17)281017(10)M50930 Lot Number: M50930 Expiration Date: 10/17/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251113(17)281113(10)M51230 Lot Number: M51230 Expiration Date: 11/13/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251212(17)281212(10)M51587 Lot Number: M51587 Expiration Date: 12/12/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)260115(17)290115(10)M51696 Lot Number: M51696 Expiration Date: 01/15/2029 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250904(17)280904(10)M49921 Lot Number: M49921 Expiration Date: 09/04/2028 Model No; DVF4019-23 UDI-DI: (01)10817489022136(11)251107(17)281107(10)M51128 Lot Number: M51128 Expiration Date: 11/07/2028

    Distribution

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

    Quantity

    50 units