BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus OER-Elite

    Recall: Z-0872-2026 · Reported December 10, 2025

    Enforcement

    Recall Number
    Z-0872-2026
    Event ID
    97849
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aizu Olympus Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2025
    Initiation Date
    October 31, 2025
    Classification Date
    December 2, 2025
    Address
    3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan

    Description

    Olympus OER-Elite

    Reason

    Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

    Code Info

    Model: OER-Elite; UDI: 04953170404047; Serial #: All;

    Distribution

    US Nationwide distribution.

    Quantity

    6578 units