Z-2401-2023Class II

UroPass Ureteral Access Sheaths, 5 pieces/box

Name: Z-2401-2023 UroPass Ureteral Access Sheaths, 5 pieces/box
Creator: Olympus Corporation of the Americas
Published: 2023-05-19
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-05-19 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of UroPass Ureteral Access Sheaths, 5 pieces/box on 2023-05-19. FDA classified it as Class II and gives the reason as "Dilator tips may break in the package and in patients during surgical procedures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2401-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-08-14
Recalling firm: OLYMPUS Corporation of the Americas
Product: UroPass Ureteral Access Sheaths, 5 pieces/box
Product code: KNY Accessories, Catheter, G-U
Reason for recall: Dilator tips may break in the package and in patients during surgical procedures.
Root cause tag: manufacturing process
FDA 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 in commerce: 9520 eaches
Distribution: Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2401-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-23	2023-08-14

Product code KNY

K051593Class IIUropass Ureteral Access Sheath, Model 61224Acmi Corporation / cleared 2005-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)