BEUDAMED
    FDA Enforcement Class II Ongoing

    Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2187-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2187-2026
    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 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825006877, Lot Numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    108 units