FDA-Device2026-05-20Class IIPROCESSING DEFECT
DJO DONJOY ICEMAN CLASSIC3 cold therapy unit recalled for broken connector risk
OTHERNationwide distribution
DJO DONJOY ICEMAN cold therapy unit recalled for connector failure
Some DJO DONJOY ICEMAN CLASSIC3 cold therapy units (model 11-1422) may have a broken connector that could temporarily stop the cold therapy from working as prescribed. The connector failure affects specific production lots and has been identified in devices distributed across the U.S. and Canada. No injuries have been reported.
- Check if your ICEMAN CLASSIC3 unit is model 11-1422 with lot code 101325 or 101425.
- If you have an affected unit, stop using it and contact DJO for instructions on repair or replacement.
- Contact your healthcare provider if you have questions about your cold therapy treatment during any service interruption.
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
1412
Manufactured in
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States
Products
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,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-2135-2026More DJO, LLC recalls
- FDA-Device2026-05-20DJO DONJOY IceMan CLASSIC3 cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO DONJOY ICEMAN CLASSIC CUBE cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO IceMan CLASSIC3 cold therapy unit recalled for broken connector
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief