Cold Form Wrap: Back — Class II medical device recall Z-0722-2026
Ongoing recall by DJO, LLC, reported 2025-12-03, distributed nationwide. The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the
| Recall number | Z-0722-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DJO, LLC, Carlsbad, CA, United States |
| Recall initiated | 2025-09-25 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,594 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00888912164382, 00888912164481 |
| Lot numbers | 171221, 180821, DP163CT03-BLK-L, XL/00888912164481/150221 |
| Model numbers | DP163CT02, DP163CT03-BLK-L |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0722-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.