O — Class II medical device recall Z-1395-2024
Ongoing recall by Emergency Products & Research, reported 2024-04-03, distributed nationwide. Failure of adhesive to secure the pole insert.
| Recall number | Z-1395-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Emergency Products & Research, Kent, OH, United States |
| Recall initiated | 2024-02-27 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 190,000 units |
| Lot numbers | 09082023-11, 09082023-12, 122023-1, 122023-2, 122023-3, 20230523-04 |
| Model numbers | EP-800 |
Product
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Reason for recall
Failure of adhesive to secure the pole insert.
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-1395-2024. 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.