Z-2467-2023Class II

Evis Exera III Duodenovideoscope Olympus Tjf-Q190v

Name: Z-2467-2023 Evis Exera III Duodenovideoscope Olympus Tjf-Q190v
Creator: Olympus Corporation of the Americas
Published: 2023-07-27
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-07-27 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V on 2023-07-27. FDA classified it as Class II and gives the reason as "Recent reports of patient infection". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2467-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-27
Posted: 2023-08-28
Recalling firm: OLYMPUS Corporation of the Americas
Product: Evis Exera III Duodenovideoscope Olympus Tjf-Q190v
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Recent reports of patient infection.
FDA root cause: Under Investigation by firm
Action: Consignees were sent an Urgent Medical Corrective Action notification dated 7/27/2023. This action is being initiated due to the firm becoming aware of and FDA inquiring about recent reports of infections and positive cultures. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus Service, and informing users about an updated manual intended to improve comprehension of existing reprocessing steps. Additional enhancements to the manual include the use of reprocessing timelines and simplified text/visualization techniques. The manual is available on the customer web portal and paper copies, along with wall charts, are available to be mailed to your facility. The notification also emphasises the required inspection of the forceps elevator mechanism, to be performed once a year or every 100 reprocessing cycles, and encourages consignees to consider incorporating voluntary routine microbiologic surveillance of endoscops as part of their quality improvement/assurance efforts. Consignees are asked to complete and return the provided response form to Sedgwick via email at [email protected] or by fax to 888-208-4588. Questions can be directed by phone to 866-912-9552. Customers can also contact Ashley Mitch at Olympus by phone at 484-553-1029 or by email at [email protected] with any additional concerns.
Quantity in commerce: 6,426 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2467-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2467-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

Product code FDT

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)