Ablation Galil Technology — Class II medical device recall Z-2680-2020
Terminated recall by Boston Scientific Corporation, reported 2020-07-29, distributed nationwide. The needle surface deteriorated due to unexpected electrolysis during procedure.
| Recall number | Z-2680-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2020-06-04 |
| Classified | 2020-07-21 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2024-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 88 devices |
| UPC / GTIN / UDI-DI | 07290104831058 |
| Lot numbers | A1194, A1298, A1436, A1567, A1569, A1782, A6754, A6757, A6848, A6849, A6915, T0154, T0163, T0552, U0083 |
Product
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Reason for recall
The needle surface deteriorated due to unexpected electrolysis during procedure.
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-2680-2020. 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.