FDA Device recall Z-1911-2025
Olympus EVIS EXERA III Duodenovideoscope
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of Olympus EVIS EXERA III Duodenovideoscope by Olympus, citing recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one ho….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1911-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-05 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Reason
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Identifiers
| code_info | UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers. |
|---|
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-1911-2025%22
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