BEUDAMED
    FDA Enforcement Class II Ongoing

    BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2176-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2176-2026
    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

    BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    28 units