Reported Dec 3, 2025 · Ongoing

Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

Djo, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DJO, LLC · 5919 Sea Otter Pl Ste 200 · Carlsbad, CA · 92010-6750

Is this the product you have?

  • Cold Form WrapBack
  • REFDP163CT03-BLK-L,XL, and Shoulder
  • REFDP163CT02
Lot codes and dates
  • REF/UDI-DI/Lot
    • DP163CT02/00888912164382/190523
    • 171221. DP163CT03-BLK-L
    • XL/00888912164481/150221
    • 180821
Amount recalled
1,594

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:15 PM UTC

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