Safety Alert: Class II: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
healthClass IIRecalled on Sep 17, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
🔢 19 units
Sold At: Boston Scientific Corporation(Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy.)
Recall #: FDA-DEVICE-Z-2550-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338; FPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096 108312221, 104733618; H749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990
Get AI-Powered Summary
Premium members get instant insights to help you understand recalls faster
Instant 1-3 sentence summary
Quick action bullets
Clear guidance on what to do
Summary
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.