Recall Z-1116-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1116-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-25

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-03-25. It names one FDA 510(k) clearance: K172246. Product: Olympus Uretero-reno videoscope, Model No. URF-V2. Reason: The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-03-25
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K172246 — OLYMPUS URF-V2/V2ROlympus Medical Systems Corp.·cleared 2018-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.

Data sourced from openFDA. This site is unofficial and independent of the FDA.