UroPass Ureteral Access Sheaths, 5 pieces/box recallZ-2401-2023 · Olympus Corporation of the Americas · initiated May 19, 2023
Class II Open, Classified All recalls posted in August 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Dilator tips may break in the package and in patients during surgical procedures.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2401-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 19, 2023
- Posted by the FDA
- Aug 14, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 9520 eaches
- Product code
- KNY
- FDA submissions
- K051593
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
Product description
UroPass Ureteral Access Sheaths, 5 pieces/box
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
16 devices cleared under K051593 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- UroPass 61238BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall10 reports
- UroPass 61024BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall5 reports
- UroPass 61138BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall5 reports
- UroPass 61046BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61054BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61146BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61224BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61254BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall4 reports
- UroPass 61324BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall3 reports
- UroPass 61338BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall2 reports
- UroPass 61154BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall1 report
- UroPass 61246BXGyrus ACMI, LLC · ACCESSORIES, CATHETER, G-U1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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