← FDA ENFORCEMENT
Z-2136-2026Class 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
CA
Product quantity
480
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 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

Code / lot info

Model/Catalog Number: 11-1424 Lot Code: Lot: 110525 GTIN: 00888912017305

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.