ICEfx Cryoablation System — Class II medical device recall Z-2550-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-09-17, distributed nationwide. Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
| Recall number | Z-2550-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2025-08-18 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, IT |
| Quantity | 18 units |
| UPC / GTIN / UDI-DI | 00191506014995, 00859019006370, 00859019006417 |
| Serial numbers | 104733618, 106066356, 107799735, 107851990, 107887794, 108254011, 108312221, 108415728, 108470986, 108612524, 3779, 86643865, 88589050, 89392275, FPRCH8000-02, H749396118000, ICP0299, ICP0305, ICP0338, ICP0369, IF0096 |
Product
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Reason for recall
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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-2550-2025. 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.