Cold Form Wrap: Back recall
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Why was Cold Form Wrap: Back recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
- Product
- Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
- Recalling firm
- DJO, LLC
- Quantity
- 1,594
- 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.
- Recall date
- December 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)