BEUDAMED
    FDA Enforcement Class II Ongoing

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    Recall: Z-1361-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1361-2026
    Event ID
    98266
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2026
    Initiation Date
    May 23, 2025
    Classification Date
    February 12, 2026
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    Reason

    This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

    Code Info

    UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829

    Distribution

    US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.

    Quantity

    10 units