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FDA-Device2026-05-20Class IIPROCESSING DEFECT

DJO DONJOY ICEMAN CLASSIC CUBE cold therapy unit recalled for broken connector

DJO
OTHERNationwide distribution

DJO DONJOY ICEMAN CLASSIC CUBE recalled for connector failure

Some DONJOY ICEMAN CLASSIC CUBE cold therapy units (model 11-0494) contain a broken connector that may temporarily interrupt cold therapy during treatment. This affects units from specific lot codes distributed across the U.S. and Canada. No injuries have been reported.

  • Check if your unit matches model 11-0494 and lot codes 146894, 146895, 146856, or 146857.
  • Contact DJO, LLC or your healthcare provider if your unit is affected.
  • Do not use a malfunctioning unit for prescribed cold therapy without professional guidance.
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
596
Manufactured in
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States
Products
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE 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-2134-2026

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