DonJoy IceMan cold therapy unit recall due to broken connector
DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported injuries or hospitalizations. The hazard—interruption of cold therapy—poses risk of harm but is temporary and reversible; there is no evidence of actual injury or serious consequence in the source text.
Plain-English summary
DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit, model 11-9099, due to a broken connector that may result in a temporary interruption of prescribed cold therapy. The recalled product is a cold therapy unit designed to help reduce pain and swelling as part of rehabilitation.
The defect is a broken connector that could cause an interruption in the cold therapy being delivered as prescribed. This unit was distributed nationwide across the United States (including 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) and Canada. The affected lot is 110525 (GTIN: 00888912000376), with 96 units recalled.
If you have this device, contact DJO, LLC or your healthcare provider for further instructions on whether a replacement is needed.
The recalled product
- Product
- 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…
- Manufacturer
- DJO, LLC
- Category
- Medical Device — Cold therapy
- Affected units
- 96
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 (1)
- Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376
Distribution
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
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