BEUDAMED
    FDA Enforcement Class II Ongoing

    BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Recall: Z-2178-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2178-2026
    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 XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

    Reason

    Incomplete seals on sterile product

    Code Info

    UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.

    Distribution

    US Nationwide and the countries of Israel and Canada.

    Quantity

    90 units