Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-2401-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

UroPass Ureteral Access Sheaths, 5 pieces/box

Product Classification:

Class II

Date Initiated: May 19, 2023

Date Posted: August 23, 2023

Recall Number: Z-2401-2023

Event ID: 92495

Reason for Recall:

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

Status: Ongoing

Product Quantity: 9520 eaches

Code Information:

Models: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Lots: All products manufactured in 2018 and 2019. Manufacturing date is printed on pouch label in YYYY-MM-DD format.

Distribution Pattern:

Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated