The Recall Desk
ModerateFDA (Devices)·Z-2134-2026·Announced 2026-05-20

DonJoy IceMan Classic Cube cold therapy unit connector defect recall

DJO, LLC is recalling DONJOY ICEMAN CLASSIC CUBE cold therapy units due to broken connectors that may interrupt prescribed cold therapy. Approximately 596 units were distributed nationwide and in Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The defect causes temporary interruption of therapy rather than direct patient harm, and the source text does not indicate hospitalization or significant injury reports.

Plain-English summary

DJO, LLC is recalling the DONJOY ICEMAN CLASSIC CUBE cold therapy unit (Model 11-0494) due to a broken connector defect. The connector issue may result in a temporary interruption of prescribed cold therapy treatment.

Approximately 596 units were distributed nationwide across multiple U.S. states (including 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) and in Canada. Affected lot codes are 146894, 146895, 146856, and 146857 (GTIN: 00888912003100).

Consumers who have this product should contact their healthcare provider or DJO, LLC for instructions on how to proceed. Patients should not attempt to repair the device themselves.

The recalled product

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 pro
Manufacturer
DJO, LLC
Category
Medical Device — Cold therapy equipment
Hazard
Affected units
596

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model/Catalog Number: 11-0494 Lot Code: Lots: 146894
  • 146895
  • 146856
  • 146857 GTIN: 00888912003100

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 4 recalled by DJO, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · DJO, LLC

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Same hazard · connector failure

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