BEUDAMED
    FDA Enforcement Class II Ongoing

    Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2188-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2188-2026
    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 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    19 units