FDAClass IJuly 26, 2023

Olympus OES Bronchofiberscope BF Type recall

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Why was Olympus OES 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-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264

Product
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Recalling firm
Olympus Corporation of the Americas
Quantity
1535 units
Distribution
US Nationwide Distribution.
Recall date
July 26, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls