Stop using nowMedical device recall · FDA · Published September 25, 2025
DJO Cold Form Wrap: Microwave Heating Risk of Burns
DJO recalls back and shoulder cold wraps that may leak or burn if heated in microwave. Affected models include DP163CT02 and DP163CT03. Stop using immediately to avoid second-degree burns.
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.
“DJO Cold Form Wrap: Microwave Heating Risk of Burns.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51228-djo-cold-form-wrap-microwave-heating-risk-of-burns. Based on FDA recall #Z-0722-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2026%22&limit=1).
DJO, LLC voluntarily recalled Cold Form Wrap products on Sept. 25, 2025, after the FDA announced the items may leak or reach temperatures causing second-degree burns. The Food and Drug Administration issued the recall for Class II devices distributed nationwide.
How to tell if you have it
Brand: DJO
Product: Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL
Product: Cold Form Wrap: Shoulder, REF: DP163CT02
Lot codes: 190523, 171221, 150221, 180821
Units affected: 1,594
The hazard
The Information for Use instructs users to heat the wrap in a microwave for three minutes, which may cause it to leak or break at the seams and reach temperatures capable of causing a second-degree burn. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show DJO, LLC has four other recalls on file since June 25, 2018. Other recent recalls of similar products include DONJOY ICEMAN Cold Therapy Unit Recall (March 19, 2026) and Medline Full Electric Low Lightweight Bed Recall (Nov. 26, 2025).
How to tell if you have this one
Check for model numbers DP163CT02 (shoulder) or DP163CT03-BLK-L,XL (back) on the wrap. The recall covers specific production dates and lot numbers listed in the product description.
Brand
DJO
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled cold wraps as heating them in the microwave can cause leaks or burns.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 28 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0722-2026 (September 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0722-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.