FDA-Device2026-05-20Class IIPROCESSING DEFECT
DJO DONJOY IceMan CLASSIC3 cold therapy unit recalled for broken connector
What this means
Some DJO DONJOY IceMan CLASSIC3 cold therapy units (model 11-1424) have a broken connector that can interrupt cold therapy temporarily. This affects prescribed rehabilitation treatments. No injuries have been reported.
- Check your IceMan CLASSIC3 unit for a broken connector
- Contact DJO customer service if you own an affected unit
- Do not use the device if the connector is damaged
The agency's original wording
Hazard
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Intended for
Adults
Illnesses reported
None reported
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
480
Manufactured in
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States
Products
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH 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-2136-2026Want us to check the next one for you?
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