DJO, LLC recalls Cold Form Wrap: Back
- Recalling company
- DJO, LLC
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 25, 2025
- Reported
- Dec 3, 2025
- 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.
- Status
- Ongoing
- Quantity
- 1,594
- Lot / codes
- REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
- Company location
- Carlsbad, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0722-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0722-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.