FDA-Device2025-12-03Class IIMISBRANDING
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
BURNNationwide distribution
Hazard
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.
Sold states
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.
Affected count
1,594
Manufactured in
5919 Sea Otter Pl Ste 200, N/A, Carlsbad, CA, United States
Products
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2026More DJO, LLC recalls
- FDA-Device2026-05-20DJO DONJOY IceMan CLASSIC3 cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO DONJOY ICEMAN CLASSIC CUBE cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO DONJOY ICEMAN CLASSIC3 cold therapy unit recalled for broken connector risk
- FDA-Device2026-05-20DJO IceMan CLASSIC3 cold therapy unit recalled for broken connector
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