← FDA ENFORCEMENT
Z-0722-2026Class II

DJO, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
DJO, LLC
Product type
Device
Status
Ongoing
Report date
2025-12-03
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.
Firm state
CA
Product quantity
1,594
Initiated by
Voluntary: Firm initiated
Reason for recall

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.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →