Olympus Corporation of the Americas UroPass Ureteral Access Sheaths, 5 pieces/box Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UroPass Ureteral Access Sheaths, 5 pieces/box
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Models: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX
Products Sold
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.
Olympus Corporation of the Americas is recalling UroPass Ureteral Access Sheaths, 5 pieces/box due to Dilator tips may break in the package and in patients during surgical procedures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dilator tips may break in the package and in patients during surgical procedures.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026