FDA Device recall Z-1395-2024
O.T.D - Optimum Traction Device - Street Orange
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of O.T.D - Optimum Traction Device - Street Orange by Emergency Products And Research, citing failure of adhesive to secure the pole insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1395-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-27 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Emergency Products And Research |
| Distribution | US |
Product
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Reason
Failure of adhesive to secure the pole insert.
Identifiers
| code_info | Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1395-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.