Z-1911-2025Class II

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

Name: Z-1911-2025 Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Creator: Olympus Corporation of the Americas
Published: 2025-05-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-05-05 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V on 2025-05-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1911-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-05
Posted: 2025-06-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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].
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1911-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1911-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-05

Product code NWB

K220587Class IIEvis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. / cleared 2022-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)