[pending] Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-0579-2026.
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
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
The recalled product
- Product
- Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
- 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 (3)
- Model/Catalog Number: TJF-Q190V
- UDI: 04953170405563 / 04953170452024
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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