Z-2518-2018Class II

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

Name: Z-2518-2018 Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Creator: Olympus Corporation of the Americas
Published: 2018-01-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2018-01-17 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R on 2018-01-17. FDA classified it as Class II and gives the reason as "Potential breakage of the endoscope s insertion tube bending section during surgical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2518-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-17
Posted: 2018-07-20
Terminated: 2019-12-04
Recalling firm: OLYMPUS Corporation of the Americas
Product: Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Product code: OCS Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Reason for recall: Potential breakage of the endoscope s insertion tube bending section during surgical procedures
Root cause tag: design
FDA root cause: Device Design
Action: On 1/16/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures. Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-V2/V2R models; 2.Olympus will contact your facility to make arrangements for return of your URF-V2/V2R u videoscope(s) for the device exchange. You will be provided instructions on returning the URF-V2/V2R for this exchange; 3.Olympus has discontinued previously distributed copies of the URF-V2/V2R Reprocessing Manual and the Operation Manual. Inspect your inventory of the Reprocessing Manual and the Operation Manual, and discard any existing inventory of the URF-V2/V2R Reprocessing Manual and the Operation Manual; 4.Implement use of the enclosed Reprocessing Manual which recommends only sterilization methods, and the enclosed Operation Manual; 5. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions in the new Reprocessing Manual; 6. If you may have further distributed the URF-V2/V2R, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter; 7. Please indicate on the enclosed questionnaire that you have received this notification. Return of the enclosed questionnaire will be deemed to be a request for a new replacement URF-V2/V2R videoscope(s). Fax the completed form to 484-896-7128.
Quantity in commerce: 2548
Distribution: US Nationwide and Canada
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2518-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2518-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20

Product code OCS

K172246Class IIOlympus Urf-V2/v2rOlympus Medical Systems Corp. / cleared 2018-03-30

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)