Z-1252-2017Class II

Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended...

Name: Z-1252-2017 Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended...
Creator: Olympus Corporation of the Americas
Published: 2016-12-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2016-12-12 / Terminated

FDA source

Olympus Corporation of the Americas began a 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 and treatment... on 2016-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1252-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-02-24
Terminated: 2018-02-27
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.
Quantity in commerce: 1,627 units (769 URF-V2 and 858 URF-V2R)
Distribution: Worldwide distribution-US Nationwide and country of: Canada.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1252-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-02-24

Product code NWB

K072957Class IIEvis Exera II 180 SystemOlympus Medical Systems Corporation / cleared 2008-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)