BEUDAMED
    FDA Enforcement Class II Ongoing

    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2192-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2192-2026
    Event ID
    98708
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 20, 2026
    Initiation Date
    April 10, 2026
    Classification Date
    May 13, 2026
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327, United States

    Description

    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825007270, Lot Numbers: 4026564, 4229299, 4801695, 4953879, 4987354, 5020148, 5075816, 4062382, 4229325, 4820358, 4953880, 4993906, 5034504, 5075889, 4126798, 4274291, 4821138, 4953881, 4993907, 5034505, 5075890, 4133063, 4294908, 4835292, 4953882, 4993909, 5044394, 5075900, 4159795, 4393599, 4841302, 4972396, 4993911, 5044402, 5075908, 4185728, 4487172, 4842791, 4972397, 4998472, 5047707, 4186431, 4550977, 4857135, 4972398, 4998473, 5053484, 4202027, 4574015, 4866297, 4972399, 4998474, 5058443, 4229211, 4584299, 4872587, 4972415, 5004432, 5063958, 4229292, 4594942, 4873162, 4987352, 5014723, 5066753, 4229294, 4737174, 4881443, 4987353, 5019469, 5066980.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    107 units