FDA recall, , Moderate risk
Donjoy IceMan CLASSIC3 Cold Therapy Unit
The IceMan CLASSIC3 cold therapy unit has a broken connector that may interrupt prescribed cold therapy.
Summary by Recall Canary from the FDA notice
What happened
DJO, LLC of Carlsbad, California is recalling certain DONJOY IceMan CLASSIC3 cold therapy units because a broken connector may result in a temporary interruption of prescribed cold therapy. The affected products include the Iceman W, the Iceman Classic Cube, and the Iceman W/Coldpad. The recall began March 19, 2026, and was added to the FDA's Enforcement Report on May 8, 2026. The units were distributed nationwide in the United States and in Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
DONJOY IceMan, W/Coldpad, NS, RH
- UDI-DI
- 00888912000376
- Model/Catalog number
- 11-9099
- Lot code
- 110525
- Software version
- No
DONJOY IceMan W/,Univ,Loop,NS,EH
- UDI-DI
- 00888912017305
- Model/Catalog number
- 11-1424
- Lot code
- 110525
- Software version
- No
DONJOY IceMan Classic Cube
- UDI-DI
- 00888912003100
- Model/Catalog number
- 11-0494
- Lot code
- 146894
- 146895
- 146856
- 146857
- Software version
- no
DONJOY IceMan W/,Univ,Loop,NS,RH
- UDI-DI
- 00888912005869
- Model/Catalog number
- 11-1422
- Lot code
- 101325
- 101425
- Software version
- no
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution in the states of 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, and West Virginia. The country of Canada.
- Company
- DJO, LLCCarlsbad, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98638
- Recall numbers
- Z-2134-2026 to Z-2137-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
