Class II Recall

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Produc

Summary

The FDA issued a Class II for Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Numbe by DJO, LLC. Reason: Due to broken connector which may result in a temporary interruption of prescribed cold therapy..

Details

Source

Device Recall

External ID

Z-2136-2026

Action Date

2026-05-20

Status

Ongoing

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

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

Quantity Affected: 480

Reason for Recall

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

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-19

Company

DJO, LLC

Carlsbad, CA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.

DJO, LLC has 7 FDA actions in our database, including 7 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DJO, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does DJO, LLC have FDA actions?

DJO, LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2136-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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