Cold Form Wrap (DJO) – microwave heating risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Brand
DJO, LLC
Lot Codes / Batch Numbers
REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L, XL/00888912164481/150221, 180821
Products Sold
REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
DJO, LLC is recalling Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.