Wrap Recall: DONJOY ICEMAN 11-1424
Announced 2026-05-20 · FDA
The FDA recall involves DJO, LLC's DonJoy ICEMAN back and shoulder cold wrap (model 11-1424) distributed nationwide in the United States. The recall is due to the IFU instructing users to heat the wrap in a microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second-degree burn. Approximately 1,594 units are affected; recall numbers are DP163CT02/00888912164382/190523, 171221 and DP163CT03-BLK-L,XL/00888912164481/150221, 180821.
| Brand | DJO, LLC |
|---|---|
| Product | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 |
| Reason | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn. |
| Severity | moderate |
| Units affected | 480 |
| Distribution | US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK. |
| Agency | FDA |
| Recall / campaign no. | REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821 |
WHAT YOU SHOULD DO
- Stop using the wrap immediately and keep it away from children.
- Contact DJO, LLC to arrange replacement or disposal and follow the recall instructions, providing the recall numbers if requested.
- Do not heat or microwave the wrap again.
- If you notice a burn or skin irritation, seek medical care and keep the packaging and recall information for reference.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.