Recall Z-1911-2025 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
| Date | Jun 5, 2025 (initiated May 5, 2025) |
| Status | Open, Classified |
| Reason | Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure. |
| Root cause | Labeling design |
| Action | Olympus notified consignees on 05/05/2025 via "URGENT Medical Device Correction" letter. Consignees were instructed to carefully review the notification, ensure all reprocessing and endoscopy unit personnel are completely knowledgeable and thoroughly trained on the updated reprocessing instructions, replace any copies of the reprocessing manual with the updated version (RC8415_02), complete and return the response form to recall web portal: https://olympusamerica.com/recall, enter the recall number: "0471" and complete the form as instructed, and forward the notification to affected customers |
| Quantity | 12,195 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp., May 11, 2022 |