FDAClass IISeptember 6, 2023

Evis Exera III Duodenovideoscope Olympus Tjf-q190v recall

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Why was Evis Exera III Duodenovideoscope Olympus Tjf-q190v recalled?

Recent reports of patient infection.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.

Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Recalling firm
Olympus Corporation of the Americas
Quantity
6,426 units
Distribution
US Nationwide distribution.
Recall date
September 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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