Open, Classified

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

FDA Recall Z-1911-2025 · Posted 2025-06-05

Recalling FirmOlympus Corporation of the Americas

Recall StatusOpen, Classified

Product CodeNWB

Date Initiated2025-05-05

Product Quantity12,195 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.

Firm 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 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 [email protected].

Root Cause

Labeling design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220587Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. · 2022-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.