FDA Device recall Z-2401-2023
UroPass Ureteral Access Sheaths, 5 pieces/box
- FDA Device
- Class II
- ongoing
- Published 2023-08-23
On 2023-08-23 the FDA classified a Class II recall of UroPass Ureteral Access Sheaths, 5 pieces/box by Olympus, citing dilator tips may break in the package and in patients during surgical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2401-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-19 |
| Published | 2023-08-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
UroPass Ureteral Access Sheaths, 5 pieces/box
Reason
Dilator tips may break in the package and in patients during surgical procedures.
Identifiers
| code_info | Models: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 613…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2023%22
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