FDA Recall Open, Classified

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

Recall: Z-0722-2026 · Initiated September 25, 2025

Recall

Recall Number
Z-0722-2026
Event Number
97610
Firm
DJO, LLC
FEI Number
3017264244
Product Code
IME
Status
Open, Classified
Root Cause
Labeling Change Control
Initiated
September 25, 2025
Posted
November 26, 2025
Address
5919 Sea Otter Pl, Ste 200, Carlsbad, CA, 92010-6750

Description

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

Reason

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

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 [email protected] 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 [email protected]

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.

Quantity

1,594