Z-0579-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7023 units
Product Description
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 accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;