CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report
Ablation Galil Technology, IceFORCE 1 CX Prostate Kit recalled
Boston Scientific is recalling Ablation Galil Technology, IceFORCE 1 CX Prostate Kit Visual ICE System, Prescription, distributed nationwide in the US. The recall was initiated on 4 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2678-2020
- FDA event ID
- 85815
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2020
- FDA classified
- 21 Jul 2020
- Reported
- 29 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 4 Jun 2020 | Recall initiated by company | |
| 21 Jul 2020 | Classified by FDA | +47 days |
| 29 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The needle surface deteriorated due to unexpected electrolysis during procedure.
Product as listed by the FDA
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Where it was distributed
Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoKansasLouisianaMassachusettsMarylandMaineMinnesotaMissouri
Questions about this recall
Is Ablation Galil Technology, IceFORCE 1 CX Prostate Kit Visual ICE System, Prescription recalled?
Yes. Boston Scientific recalled Ablation Galil Technology, IceFORCE 1 CX Prostate Kit Visual ICE System, Prescription on 4 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2678-2020.
Why was it recalled?
The needle surface deteriorated due to unexpected electrolysis during procedure.
Which lots are affected?
UPN: FPRPR3605, GTIN: 7290104831034, Batch: A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, T0153
Where was it sold?
Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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