DJO, LLC: Device Recall
Recall #Z-0722-2026 · 09/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0722-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DJO, LLC
- Status
- Ongoing
- Date Initiated
- 09/25/2025
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,594
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.
Product Description
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.