Z-1251-2017Class II

URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

Name: Z-1251-2017 URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
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 URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope on 2016-12-12. FDA classified it as Class II and gives the reason as "Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1251-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-02-24
Terminated: 2018-02-26
Recalling firm: OLYMPUS Corporation of the Americas
Product: URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
Reason for recall: Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
FDA root cause: Under Investigation by firm
Action: Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken 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. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.
Quantity in commerce: 3461 units distributed to US consignees
Distribution: Distributed Nationwide
Product codes and lots: All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-02-24

Product code FBN

K912120Class IIUrf-P2 Ureterorenofiberscope/choledochofiberscopeOlympus Corp. / cleared 1991-08-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)