Boston Scientific Zurpaz — Class II medical device recall Z-2529-2017
Terminated recall by Creganna Medical Devices, reported 2017-06-21. Lack of sterility assurance.
| Recall number | Z-2529-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Creganna Medical Devices, Galway, N/A, Ireland |
| Recall initiated | 2017-05-22 |
| Classified | 2017-06-13 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2018-05-29 |
| Quantity | 85 units |
| Reason classes | sterility |
| Lot numbers | 364951, 385149 |
| Model numbers | M004USTMCA85200 |
Product
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
Reason for recall
Lack of sterility assurance.
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-2529-2017. 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.