IceCure Cryoablation System ProSense -Intended for cryogenic… — Class II medical device recall Z-2650-2023
Ongoing recall by Icecure Medical Ltd, reported 2023-10-11, distributed nationwide. Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g.
| Recall number | Z-2650-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Icecure Medical Ltd, Caesarea, N/A, Israel |
| Recall initiated | 2019-09-16 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 07290015487160, 07290015487290 |
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)
Reason for recall
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
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-2650-2023. 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.