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

FDA device recall Z-0722-2026 · posted 2025-11-26 · Open, Classified

Recall details

Recalling firm

DJO, LLC

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.

Action taken

Per recall notice, customers were asked to do the following: Users should immediately discontinue all further use of this product and discard any opened/used units. If you have unopened, unused units in your possession, please contact firm Customer Service at (844) 331-7767. You will be provided with a return authorization number and shipping label that is required for proper return and identification of the device. All users must complete the acknowledgement and response form and return to productsafety@enovis.com This notice must be distributed to all those within your organization and to any other organization, consignee, or user where these products were transferred. If you have any questions you can reach the firm via email at productsafety@enovis.com

Root cause

Labeling Change Control

Status

Open, Classified

Product code

IME

Quantity affected

1,594

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.

Date initiated

2025-09-25

Date posted

2025-11-26

Location

Carlsbad, CA