Olympus EVIS EXERA III Duodenovideoscope recall: Contamination
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Why was Olympus EVIS EXERA III Duodenovideoscope recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
- Product
- Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
- Recalling firm
- Olympus Corporation of the Americas
- 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 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.
- Recall date
- June 11, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)