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Open, Classified

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

FDA Recall Z-0722-2026 · Posted 2025-11-26

Recalling FirmDJO, LLC
Recall StatusOpen, Classified
Product CodeIME
Date Initiated2025-09-25
Product Quantity1,594

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.

Firm 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]

Root Cause

Labeling Change Control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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