BEUDAMED
    FDA Enforcement Class II Ongoing

    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

    Recall: Z-0268-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0268-2025
    Event ID
    95426
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 18, 2024
    Classification Date
    October 30, 2024
    Address
    15353 Barranca Pkwy, N/A, Irvine, CA, 92618-2216, United States

    Description

    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each

    Reason

    Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

    Code Info

    Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers

    Distribution

    U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A

    Quantity

    64