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Recall Observatory FDA recall evidence

Device product

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

Z-0722-2026

September 25, 2025

Class II

Product summary

Firm
DJO, LLC
Event
Event 97610
Status
Ongoing
Classification
Class II
Quantity
1,594
Official record key
device-enforcement:Z-0722-2026

Official wording

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.

Code information: REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.