DJO, LLC: Medical Device Recall in 2025 - (Recall #: Z-0722-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 25, 2025

Date Posted: December 3, 2025

Recall Number: Z-0722-2026

Event ID: 97610

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.

Status: Ongoing

Product Quantity: 1,594

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.

Voluntary or Mandated:

Voluntary: Firm initiated