UroPass Ureteral Access Sheaths — Class II medical device recall Z-2401-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-08-23, distributed nationwide. Dilator tips may break in the package and in patients during surgical procedures.
| Recall number | Z-2401-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-05-19 |
| Classified | 2023-08-14 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, HK, JP, KR, TW |
| Quantity | 9,520 eaches |
| Reason classes | device malfunction |
| Model numbers | 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX |
Product
UroPass Ureteral Access Sheaths, 5 pieces/box
Reason for recall
Dilator tips may break in the package and in patients during surgical procedures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2401-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.