FDAClass IIDecember 22, 2021

Evis Exera II Duodenovideoscope Olympus Tjf-q180v recall: Contamination

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Why was Evis Exera II Duodenovideoscope Olympus Tjf-q180v recalled?

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

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?

All serial numbers. UDI: 04953170339967

Product
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Recalling firm
Olympus Corporation of the Americas
Quantity
14,447 units
Distribution
US Nationwide distribution.
Recall date
December 22, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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