CLASS I ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report

Olympus Evis Exera Iii Bronchovideoscope BF Type recalled

Olympus Corporation of the Americas is recalling Olympus Evis Exera Iii Bronchovideoscope BF Type, distributed nationwide in the US. The recall was initiated on 8 Jun 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778

Quantity recalled9,684 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2017-2023
FDA event ID: 92362
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class I
Status: Ongoing
Recall initiated: 8 Jun 2023
FDA classified: 17 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jun 2023	Recall initiated by company
17 Jul 2023	Classified by FDA	+39 days
26 Jul 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778

Where was it sold?

US Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 92362

This product is part of a recall event; the main page for the event is Olympus Bronchofiberscope BF Type recalled by Olympus Corporation of the.

Reported	Class	Recall	Company	Reason	Where
26 Jul 2023	CLASS I	Olympus Bronchofiberscope BF Type recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
26 Jul 2023	CLASS I	Olympus Bronchovideoscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
26 Jul 2023	CLASS I	Olympus Evis Exera Bronchovideoscope BF Type recalled	Olympus Corporation of the Americas	Other	Nationwide
26 Jul 2023	CLASS I	Olympus OES Bronchofiberscope BF Type recalled	Olympus Corporation of the Americas	Other	Nationwide
26 Jul 2023	CLASS I	Olympus Bronchovideoscope BF Type recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
26 Jul 2023	CLASS I	Olympus Evis Exera II Bronchovideoscope BF Type recalled	Olympus Corporation of the Americas	Other	Nationwide

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