CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report

Bronchovideoscope BF-P240 recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Bronchovideoscope BF-P240, distributed nationwide in the US. The recall was initiated on 8 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lot codes

Quantity recalled2163

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-3298-2018
FDA event ID: 80925
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 8 Aug 2018
FDA classified: 29 Sep 2018
Reported: 10 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

8 Aug 2018	Recall initiated by company
29 Sep 2018	Classified by FDA	+52 days
10 Oct 2018	Published in enforcement report	+11 days

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

Reason for recall

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Bronchovideoscope BF-P240

Where it was distributed

The products were distributed US nationwide and Canada.

Nationwide

Questions about this recall

Is Bronchovideoscope BF-P240 recalled?

Yes. Olympus Corporation of the Americas recalled Bronchovideoscope BF-P240 on 8 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-3298-2018.

Why was it recalled?

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Which lots are affected?

all lot codes

Where was it sold?

The products were distributed US nationwide and Canada.

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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