Recall Z-0722-2026— DJO, LLC

Name: FDA recall Z-0722-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-25

Class II · Ongoing

Class II FDA medical device recall by DJO, LLC, initiated 2025-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: DJO, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-25
Firm location: Carlsbad, CA, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.