FDAClass INovember 15, 2023

Evis Exera II Bronchovideoscope Olympus BF Type recall

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180

Why was Evis Exera II Bronchovideoscope Olympus BF Type recalled?

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

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 BF-1T180 UDI-DI: N/A; Model BF-1TQ180 UDI-DI: N/A; Model BF-P180 UDI-DI: N/A;

Product
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Recalling firm
Olympus Corporation of the Americas
Quantity
13950 devices
Distribution
US Nationwide distribution
Recall date
November 15, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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