Class II — Icecure Medical Ltd
| Recalling firm | IceCure Medical Ltd. |
|---|---|
| Registered facility | ICECURE MEDICAL LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) |
| Product | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC) |
| Quantity | 16 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2019-09-16 |
| Classified | 2023-09-29 |
| Recall number | Z-2650-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Icecure Medical Ltd (Z-2650-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92945/
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