Recall Z-2401-2023— Olympus Corporation of the Americas

Name: FDA recall Z-2401-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-05-19. It names one FDA 510(k) clearance: K051593. Product: UroPass Ureteral Access Sheaths, 5 pieces/box. Reason: Dilator tips may break in the package and in patients during surgical procedures..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-05-19
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation·cleared 2005-09-02

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

UroPass Ureteral Access Sheaths, 5 pieces/box

Reason for recall

Dilator tips may break in the package and in patients during surgical procedures.

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