Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
This recall is currently active, issued June 5, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- May 5, 2025
- Posted
- June 5, 2025
- Recall Number
- Z-1911-2025
- Quantity
- 12,195 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Guadeloupe, Guatemala, Honduras, Hong Kong, Iceland, India, Iraq, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Palestinian Authority, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Republic of the Congo, R¿union, Russia, Saudi Arabia, Senegal, Seychelles, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam, Yemen.
Lot / Code Info
UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Root Cause
Labeling design
Action Taken
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 if the affected product has been further distributed. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.