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Recall Observatory FDA recall evidence

Device product

UroPass Ureteral Access Sheaths, 5 pieces/box

Z-2401-2023

May 19, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92495
Status
Ongoing
Classification
Class II
Quantity
9520 eaches
Official record key
device-enforcement:Z-2401-2023

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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