CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report

Ablation Galil Technology, IceFORCE 1 CX Needle recalled

Boston Scientific is recalling Ablation Galil Technology, IceFORCE 1 CX Needle Cryoablation Needle, Prescription Only, 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

Lot, batch or date codesUPN: FPRPR3604, GTIN: 7290104831027, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041 A1203, A1549, A6734, A6916, A6928, A6931, A7083, T0156, T0166, U0042

Quantity recalled39 devices

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-2677-2020
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 Needle Cryoablation Needle, 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 Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Kansas Louisiana Massachusetts Maryland Maine Minnesota Missouri

Questions about this recall

Is Ablation Galil Technology, IceFORCE 1 CX Needle Cryoablation Needle, Prescription Only recalled?

Yes. Boston Scientific recalled Ablation Galil Technology, IceFORCE 1 CX Needle Cryoablation Needle, Prescription Only on 4 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2677-2020.

Why was it recalled?

The needle surface deteriorated due to unexpected electrolysis during procedure.

Which lots are affected?

UPN: FPRPR3604, GTIN: 7290104831027, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041 A1203, A1549, A6734, A6916, A6928, A6931, A7083, T0156, T0166, U0042

Where was it sold?

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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