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Open, Classified

UroPass Ureteral Access Sheaths, 5 pieces/box

FDA Recall Z-2401-2023 · Posted 2023-08-14

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeKNY
Date Initiated2023-05-19
Product Quantity9520 eaches

Reason for Recall

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

Firm Action

A customer notification letter was issued to customers on May 19, 2023. Customers were requested to identify affected product; cease and quarantine any product manufactured prior to December 31, 2019. Acknowledgement of receipt should be made to Olympus per the instructions in the recall letter.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation · 2005-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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