Z-2134-2026Class II

DJO, LLC

Recalling firm

DJO, LLC

Product type

Device

Status

Ongoing

Report date

2026-05-20

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.

Firm state

Product quantity

596

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

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

Code / lot info

Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.