FDAClass IJuly 26, 2023

Olympus Evis Exera Bronchovideoscope BF Type recall

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

Why was Olympus Evis Exera Bronchovideoscope BF Type recalled?

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

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 BF-XT160* EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 UDI: 04953170340147

Product
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Recalling firm
Olympus Corporation of the Americas
Quantity
284 units
Distribution
US Nationwide Distribution.
Recall date
July 26, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls