FDA Device recall Z-2674-2020

Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intende…

FDA Device
Class II
terminated
Published 2020-07-29

On 2020-07-29 the FDA classified a Class II recall of Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intende… by Boston Scientific, citing the needle surface deteriorated due to unexpected electrolysis during procedure.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2674-2020
Classification	Class II
Status	terminated
Initiated	2020-06-04
Published	2020-07-29
Last updated	2026-09-13 11:55 UTC
Company	Boston Scientific
Distribution	US

Product

Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Reason

The needle surface deteriorated due to unexpected electrolysis during procedure.

Identifiers

code_info	UPN: FPRPR3601, GTIN: 07290104830990, Batch numbers: A0735, A0736, A0749, A0750, A0798, A0799, A0817, A0818, A0840, A0… UPN: FPRPR3601, GTIN: 07290104830990, Batch numbers: A0735, A0736, A0749, A0750, A0798, A0799, A0817, A0818, A0840, A0841, A0874, A0875, A0888, A0889, A0898, A0899, A0945, A0946, A0950, A0951, A0992, A0993, A1003, A1004, A1005, A1006, A1012, A1027, A1028, A1078, A1079, A1090, A1091, A1096, A1097, A1098, A1099, A1111, A1112, A1143, A1144, A1155, A1156, A1168, A1169, A1190, A1191, A1192, A1204, A1205, A1223, A1224, A1232, A1233, A1268, A1271, A1272, A1296, A1297, A1299, A1300, A1302, A1303, A1343, A1344, A1348, A1349, A1369, A1370, A1393, A1394, A1408, A1409, A1417, A1418, A1438, A1439, A1440, A1441, A1454, A1455, A1499, A1500, A1509, A1510, A1516, A1517, A1520, A1538, A1539, A1540, A1541, A1546, A1547, A1553, A1554, A1580, A1581, A1599, A1600, A1603, A1604, A1606, A1617, A1618, A1619, A1649, A1650, A1651, A1652, A1665, A1666, A1674, A1675, A1680, A1681, A1686, A1687, A1734, A1735, A1749, A1750, A1772, A1773, A1797, A1798, A1809, A1810, A1828, A1829, A1853, A1854, A1869, A1870, A1885, A

code_info

UPN: FPRPR3601, GTIN: 07290104830990, Batch numbers: A0735, A0736, A0749, A0750, A0798, A0799, A0817, A0818, A0840, A0…

UPN: FPRPR3601, GTIN: 07290104830990, Batch numbers: A0735, A0736, A0749, A0750, A0798, A0799, A0817, A0818, A0840, A0841, A0874, A0875, A0888, A0889, A0898, A0899, A0945, A0946, A0950, A0951, A0992, A0993, A1003, A1004, A1005, A1006, A1012, A1027, A1028, A1078, A1079, A1090, A1091, A1096, A1097, A1098, A1099, A1111, A1112, A1143, A1144, A1155, A1156, A1168, A1169, A1190, A1191, A1192, A1204, A1205, A1223, A1224, A1232, A1233, A1268, A1271, A1272, A1296, A1297, A1299, A1300, A1302, A1303, A1343, A1344, A1348, A1349, A1369, A1370, A1393, A1394, A1408, A1409, A1417, A1418, A1438, A1439, A1440, A1441, A1454, A1455, A1499, A1500, A1509, A1510, A1516, A1517, A1520, A1538, A1539, A1540, A1541, A1546, A1547, A1553, A1554, A1580, A1581, A1599, A1600, A1603, A1604, A1606, A1617, A1618, A1619, A1649, A1650, A1651, A1652, A1665, A1666, A1674, A1675, A1680, A1681, A1686, A1687, A1734, A1735, A1749, A1750, A1772, A1773, A1797, A1798, A1809, A1810, A1828, A1829, A1853, A1854, A1869, A1870, A1885, A

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2674-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.