# FDA recall Z-0722-2026

> **DJO, LLC** · Class II · device recall initiated 2025-09-25.

## Product

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

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0722-2026
- **Recalling firm:** DJO, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-25
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2026

## Citation

> AI Analytics. FDA recall Z-0722-2026. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0722-2026. Source: US FDA. Licensed CC0.

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