BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

    Recall: Z-2137-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2137-2026
    Event ID
    98638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DJO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    May 8, 2026
    Address
    5919 Sea Otter Pl Ste 200, Carlsbad, CA, 92010-6750, United States

    Description

    Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

    Reason

    Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

    Code Info

    Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.

    Quantity

    96