BEUDAMED
    FDA Enforcement Class II Ongoing

    Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

    Recall: Z-0722-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0722-2026
    Event ID
    97610
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DJO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    December 3, 2025
    Initiation Date
    September 25, 2025
    Classification Date
    November 26, 2025
    Address
    5919 Sea Otter Pl Ste 200, N/A, Carlsbad, CA, 92010-6750, United States

    Description

    Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

    Reason

    The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.

    Code Info

    REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821

    Distribution

    US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.

    Quantity

    1,594