FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: UroPass Ureteral Access Sheaths, 5 pieces/box
- Recall number
- Z-2401-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- UroPass Ureteral Access Sheaths, 5 pieces/box
- Status
- Open, Classified
- Initiated
- 2023-05-19
- Posted
- 2023-08-14
- Terminated
- not on file
- Reason
- Dilator tips may break in the package and in patients during surgical procedures.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 9520 eaches
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K051593"]
- PMA numbers
- not on file
- Product code
- KNY
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28