FDAClass IJuly 26, 2023

Olympus Bronchofiberscope BF Type recall

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

Why was Olympus Bronchofiberscope 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-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998

Product
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Recalling firm
Olympus Corporation of the Americas
Quantity
4 units
Distribution
US Nationwide Distribution.
Recall date
July 26, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls