UroPass Ureteral Access Sheaths recall
UroPass Ureteral Access Sheaths, 5 pieces/box
Why was UroPass Ureteral Access Sheaths recalled?
Dilator tips may break in the package and in patients during surgical procedures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- UroPass Ureteral Access Sheaths, 5 pieces/box
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 9520 eaches
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
- Recall date
- August 23, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)