Olympus Corporation of the Americas: Brand Name: EVIS EXERA III Duodenovideoscope Product

Olympus Corporation of the Americas: Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This in

Medical DevicesSource: FDA (device) · Date: 2025-12-03

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Olympus Corporation of the Americas
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 accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Reason / hazard: 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.
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution.
Recall initiated: 2025-10-14
Code info: Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;
Product quantity: 7023 units
Voluntary mandated: Voluntary: Firm initiated
City: Center Valley
State: PA
Country: United States
Event id: 97681