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

FDA device recall Z-1911-2025 · posted 2025-06-05 · Open, Classified

Recall details

Recalling firm: Olympus Corporation of the Americas
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.
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.
Root cause: Labeling design
Status: Open, Classified
Product code: NWB
Quantity affected: 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, Ca
Date initiated: 2025-05-05
Date posted: 2025-06-05
Location: Center Valley, PA

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Related 510(k) clearances

Record	Firm	Date
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K220587)	Olympus Medical Systems Corp.	2022-05-11