CLASS I ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Evis Exera Iii Bronchovideoscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Evis Exera Iii Bronchovideoscope, distributed nationwide in the US. The recall was initiated on 12 Oct 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198

Quantity recalled32211 devices

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-0192-2024
FDA event ID: 93052
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class I
Status: Ongoing
Recall initiated: 12 Oct 2023
FDA classified: 9 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Oct 2023	Recall initiated by company
9 Nov 2023	Classified by FDA	+28 days
15 Nov 2023	Published in enforcement report	+6 days

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

Reason for recall

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.

Product as listed by the FDA

EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170

Where it was distributed

US Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model BF-1TH190 UDI-DI: 4953170335181; Model BF-H190 UDI-DI: 4953170335174; Model BF-Q170 UDI-DI: 4953170342912 Model BF-Q190 UDI-DI: 4953170335198

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

5 other products · FDA event 93052

This product is part of a recall event; the main page for the event is Evis Exera Iii Bronchovideoscope Olympus recalled.

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023	CLASS I	Evis Exera Iii Bronchovideoscope Olympus recalled	Olympus Corporation of the Americas	Other	Nationwide
15 Nov 2023	CLASS I	Evis Exera b Bronchovideoscope Olympus recalled	Olympus Corporation of the Americas	Other	Nationwide
15 Nov 2023	CLASS I	Bronchovideoscope Olympus Bf Type recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
15 Nov 2023	CLASS I	Evis Exera Ii Bronchovideoscope Olympus Bf Type recalled	Olympus Corporation of the Americas	Other	Nationwide
15 Nov 2023	CLASS I	Evis Exera Ii Bronchovideoscope Olympus Bf Type recalled	Olympus Corporation of the Americas	Other	Nationwide

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