CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report

Uretero-reno videoscope Urf-V2 Uretero-reno videoscope Urf-V2R recalled

Olympus Corporation of the Americas is recalling Uretero-reno videoscope Urf-V2 Uretero-reno videoscope Urf-V2R, distributed nationwide in the US. The recall was initiated on 17 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled2548

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-2518-2018
FDA event ID: 79622
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Jan 2018
FDA classified: 20 Jul 2018
Reported: 1 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 Jan 2018	Recall initiated by company
20 Jul 2018	Classified by FDA	+184 days
1 Aug 2018	Published in enforcement report	+12 days

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

Reason for recall

Potential breakage of the endoscope s insertion tube bending section during surgical procedures

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

Where it was distributed

US Nationwide and Canada

Nationwide

Questions about this recall

Why was it recalled?

Potential breakage of the endoscope s insertion tube bending section during surgical procedures

Which lots are affected?

All Serial Numbers

Where was it sold?

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 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.

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