CLASS II ONGOING Device recall · Reported 6 Sep 2023 · FDA Enforcement Report

Olympus Bronchovideoscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Bronchovideoscope, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04953170308130, 04953170339219, 04953170051142, & 04953170442667; All Serial Numbers.

Quantity recalled881 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-2502-2023
FDA event ID: 92779
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jul 2023
FDA classified: 31 Aug 2023
Reported: 6 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Jul 2023	Recall initiated by company
31 Aug 2023	Classified by FDA	+35 days
6 Sep 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

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Product as listed by the FDA

Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Olympus Bronchovideoscope recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Bronchovideoscope on 27 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2502-2023.

Why was it recalled?

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Which lots are affected?

UDI-DI: 04953170308130, 04953170339219, 04953170051142, & 04953170442667; All Serial Numbers.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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