Home/Recalls/FDA-Z-2137-2026
FDA DevicesClass II

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Numbe...

Published: May 20, 2026Recall ID: Z-2137-2026Category: devicesCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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

Affected Products

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, 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

Additional Source Details

FieldValue
CityCarlsbad
StateCA
Event id98638
Address 15919 Sea Otter Pl Ste 200
Code infoModel/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376
Postal code92010-6750
Report date20260520
Product typeDevices
Product quantity96
Reason for recallDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260319
Initial firm notificationLetter
Center classification date20260508

Overview

  • Recalling FirmDJO, LLC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - 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.
Official Agency Alert