CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Olympus Pleuravideoscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Pleuravideoscope, distributed nationwide in the US. The recall was initiated on 23 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial numbers

Quantity recalled265 total

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-1763-2020
FDA event ID: 85208
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 23 Mar 2020
FDA classified: 22 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Mar 2020	Recall initiated by company
22 Apr 2020	Classified by FDA	+30 days
29 Apr 2020	Published in enforcement report	+7 days

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

Reason for recall

There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

Product as listed by the FDA

Olympus Pleuravideoscope, Model LTF-240

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Is Olympus Pleuravideoscope recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Pleuravideoscope on 23 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1763-2020.

Why was it recalled?

There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

Which lots are affected?

All Serial numbers

Where was it sold?

US Nationwide

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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