FDA Medical devices recall ·
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit… recall
- Recall number
- Z-2550-2025
- Date
- (initiated August 18, 2025)
- Company / brand
- Boston Scientific Corporation
1 Scimed Pl, Maple Grove, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Why was it recalled?
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy. (Preventive Maintenance Kit distributed to Canada only.)
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2550-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.