Recall Z-0722-2026
Djo, LLC · initiated September 25, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Codes / lots: REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
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.
FDA-determined cause: Labeling Change Control
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
Details
- Recall number
- Z-0722-2026
- Initiated
- September 25, 2025
- Posted by FDA
- November 26, 2025
- Product code
- IME – Pack, Hot Or Cold, Reusable
- Quantity
- 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.
- Recalling firm
- Djo, LLC, Carlsbad, CA