Olympus Corporation of the Americas: Device Recall

Recall #Z-1911-2025 · 05/05/2025

Class II: Risk

Recall Details

Recall Number
Z-1911-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
05/05/2025
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,195 units

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.

Product Description

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

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.

Other Recalls by Olympus Corporation of the Americas

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.