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FDASeptember 25, 2025device

Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

djo

UPCs

0088891216438200888912164481

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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