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.
This recall is currently active, issued November 21, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- October 14, 2025
- Posted
- November 21, 2025
- Recall Number
- Z-0579-2026
- Quantity
- 7023 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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
US Nationwide distribution.
Lot / Code Info
Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;
Root Cause
Device Design
Action Taken
On October 14, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Carefulle read the notification and ensure that all personnel are completely knowledgeable and thoroughly trained on the content of the letter. Complete the required training provided in the letter. Keep a copy of the notification with the operation manual. It is recommended to receive on-site TJF duodenoscope reprocessing training at your facility. If you have further distributed this product, identify and forward them this notification.