Home / Recalls / Olympus Corporation of the Americas / Z-1911-2025

Z-1911-2025 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
June 11, 2025
Initiation Date
May 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,195 units

Product Description

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

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 Pattern

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.

Code Information

UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.

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