Z-0579-2026Class II

Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V...

Name: Z-0579-2026 Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V...
Creator: Olympus Corporation of the Americas
Published: 2025-10-14
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-14 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended... on 2025-10-14. FDA classified it as Class II and gives the reason as "Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0579-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-14
Posted: 2025-11-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Root cause tag: design
FDA root cause: Device Design
Action: On October 14, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Carefulle read the notification and ensure that all personnel are completely knowledgeable and thoroughly trained on the content of the letter. Complete the required training provided in the letter. Keep a copy of the notification with the operation manual. It is recommended to receive on-site TJF duodenoscope reprocessing training at your facility. If you have further distributed this product, identify and forward them this notification.
Quantity in commerce: 7023 units
Distribution: US Nationwide distribution.
Product codes and lots: Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0579-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0579-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-21

Product code FDT

K251867Class IIEvis Exera III Duodenovideoscope Olympus Tjf-Q190v (Tjf-Q190v)Olympus Medical Systems Corp. / cleared 2025-09-19

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)