BEUDAMED
    FDA Enforcement Class II Ongoing

    Mito Red Light, Super Mobile

    Recall: Z-2478-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2478-2026
    Event ID
    98999
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MITO RED LIGHT INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 24, 2026
    Initiation Date
    February 12, 2025
    Classification Date
    June 17, 2026
    Address
    9319 N 94th Way Ste 400, Scottsdale, AZ, 85258-5565, United States

    Description

    Mito Red Light, Super Mobile

    Reason

    The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

    Code Info

    All Serial/Lot numbers/No UDI

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, New Zealand, Spain, Switzerland, United Arab Emirates, United Kingdom.