BEUDAMED
    FDA Enforcement Class II Ongoing

    Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

    Recall: Z-2068-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2068-2026
    Event ID
    98753
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mint Medical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    May 6, 2026
    Address
    Friedrich-Ebert-Str. 2, Dossenheim, N/A, Germany

    Description

    Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

    Reason

    If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.

    Code Info

    Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

    Quantity

    101 systems