[pending] Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Pending LLM rewrite. Source: FDA_DEVICE Z-1911-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Distribution
Distributed nationwide across the United States.
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