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FDA-Device2026-05-20Class IIPROCESSING DEFECT

DJO IceMan CLASSIC3 cold therapy unit recalled for broken connector

DJO
OTHERNationwide distribution

DJO IceMan cold therapy unit recalled for connector failure

Some DJO IceMan CLASSIC3 cold therapy units (model 11-9099, lot 110525) have a broken connector that may temporarily interrupt cold therapy during treatment. No injuries have been reported. The issue affects about 96 units distributed across the US and Canada.

  • Check your IceMan unit for any loose or damaged connectors.
  • If you experience interruptions in cold therapy, stop using the unit and contact DJO for a replacement.
  • Contact DJO customer service if you have this model and lot number.
Hazard

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

Sold states
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.
Affected count
96
Manufactured in
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2137-2026

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