Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Des
FDA device recall Z-0579-2026 · posted 2025-11-21 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FDT
- Quantity affected
- 7023 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-10-14
- Date posted
- 2025-11-21
- Location
- Center Valley, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (K251867) | Olympus Medical Systems Corp. | 2025-09-19 |