RecallRadar

FDA Device recall Z-1252-2017

Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis…

On 2017-03-08 the FDA classified a Class II recall of Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis… by Olympus, citing olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1252-2017
ClassificationClass II
Statusterminated
Initiated2016-12-12
Published2017-03-08
Last updated2026-09-13 11:54 UTC
CompanyOlympus
DistributionUS

Product

Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.

Reason

Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.

Identifiers

code_infoAll serial numbers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1252-2017%22

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