Z-1116-2022Class II

Olympus Uretero-reno videoscope, Model No. URF-V2

Name: Z-1116-2022 Olympus Uretero-reno videoscope, Model No. URF-V2
Creator: Olympus Corporation of the Americas
Published: 2022-03-25
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-03-25 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Uretero-reno videoscope, Model No. URF-V2 on 2022-03-25. FDA classified it as Class II and gives the reason as "The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1116-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-25
Posted: 2022-05-19
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Uretero-reno videoscope, Model No. URF-V2
Product code: NWB Endoscope, Accessories, Narrow Band Spectrum
Reason for recall: The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
FDA root cause: Process change control
Action: On March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of AZ.
Product codes and lots: 1 unit, serial number 2825505F UDI 04953170343582

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-19

Product code NWB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)