Medical Device Recall: Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
DJO, LLC · September 25, 2025
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.
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.
States Affected
NATIONWIDE
Quantity Affected
1,594
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0722-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.