BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

    Recall: Z-1568-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1568-2026
    Event ID
    98429
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Erbe USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2026
    Initiation Date
    February 12, 2026
    Classification Date
    March 20, 2026
    Address
    2225 Northwest Pkwy SE, Marietta, GA, 30067-8764, United States

    Description

    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use

    Reason

    Probes may rupture/burst during activation

    Code Info

    UDI: 04050147021846/ Expanded Lots:WO472498 WO472499 WO472615 WO472616 WO473794 WO473795 WO474908 WO474909 WO474910 WO475357 WO475358 WO477030 WO477513 WO477514 WO478643 WO478646 WO478647 WO478648 WO478843 WO478844;Initial Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863

    Distribution

    US Nationwide distribution, including Puerto Rico.

    Quantity

    3603 units