FDA Medical devices recall ·
DONJOY Product Name: ICEMAN CLASSIC CUBE Model recall
- Recall number
- Z-2134-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- Djo, LLC
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 596
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: 11-0494 Lot Code: Lots: 146894, 146895, 146856, 146857 GTIN: 00888912003100
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.
States: Alaska Alabama Arizona California Colorado Florida Georgia Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Carolina Nebraska New York Ohio Oklahoma Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2134-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.