The Synchro2 Guidewires are a steerable guidewire recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog/UDI-DI/Lots: M00326110/04546540688736/0000064108, 0000065017, 0000065616, 0000066470, 0000066581, 0000067561, 0000067801, 0000068246, 0000069276, 0000071094, 0000071841, 0000073548, 0000075207, 0000077751, 0000078371, 0000078837, 0000080548, 0000080988, 0000082965, 0000083195, 0000086130, 0000088254, 0000092394, 0000092395, 0000092396, 0000095029, 0000097492, 0000098543, 0000104203, 0000111901, 0000122898, 0000123072, 0000123529, 0000126054, 0000126497, 0000126852, 0000134099, 0000135605, 0000135804, 0000144373, 0000145738, 0000145739, 0000146146, 0000146147, 0000150989, 0000153606, 0000162889, 0000162890, 0000162891, 0000172273, 0000174770, 0000175634, 0000175636, 0000175637; M00326320/04546540688750/0000105764, 0000109900, 0000181399; M00326010/04546540688729/0000063878, 0000063985, 0000064269, 0000064281, 0000064309, 0000064357, 0000064360, 0000064370, 0000064796, 0000065004, 0000065161, 0000065227, 0000065269, 0000065449, 0000065450, 0000065733, 0000065760, 0000065781, 0000065819, 0000065891, 0000066007, 0000066076, 0000066129, 0000066311, 0000066337, 0000066383, 0000066490, 0000066583, 0000066931, 0000066988, 0000067168, 0000067331, 0000067453, 0000067466, 0000067566, 0000067655, 0000067710, 0000067762, 0000067898, 0000068187, 0000068245, 0000068428, 0000068556, 0000069385, 0000069506, 0000069549, 0000069573, 0000069755, 0000069788, 0000069918, 0000070038, 0000070039, 0000070422, 0000070863, 0000071213, 0000071374, 0000071375, 0000071839, 0000071840, 0000073408, 0000073409, 0000073514, 0000073888, 0000074665, 0000074666, 0000074951, 0000074952, 0000075877, 0000076063, 0000076064, 0000076161, 0000076162, 0000076379, 0000076454, 0000077608, 0000077609, 0000077610, 0000078110, 0000078111, 0000078271, 0000078369, 0000078877, 0000078902, 0000080915, 0000080987, 0000081397, 0000081454, 0000081670, 0000082734, 0000082735, 0000084656, 0000084657, 0000084861, 0000084864, 0000085365, 0000085953, 0000086129, 0000086175, 0000086200, 0000086337, 0000087870, 0000087871, 0000087872, 0000088367, 0000088651, 0000088652, 0000090311, 0000091480, 0000091715, 0000092004, 0000092839, 0000093332, 0000093534, 0000094776, 0000094818, 0000095080, 0000095172, 0000096911, 0000096912, 0000097447, 0000097951, 0000098059, 0000099701, 0000099702, 0000099953, 0000100863, 0000100925, 0000100986, 0000102835, 0000102934, 0000103038, 0000103039, 0000104204, 0000104522, 0000104523, 0000106631, 0000106632, 0000106718, 0000107496, 0000107498, 0000108264, 0000108487, 0000109375, 0000109781, 0000109782, 0000109899, 0000111454, 0000111900, 0000112880, 0000112881, 0000113135, 0000113476, 0000113477, 0000113681, 0000114843, 0000114844, 0000114845, 0000115168, 0000116702, 0000116703, 0000117042, 0000117043, 0000121693, 0000121695, 0000122112, 0000122257, 0000122470, 0000123530, 0000123902, 0000123982, 0000123984, 0000125041, 0000125147, 0000125714, 0000125715, 0000126047, 0000126048, 0000126049, 0000126496, 0000128252, 0000128618, 0000128619, 0000128620, 0000129206, 0000129207, 0000130642, 0000130824, 0000130864, 0000130865, 0000132955, 0000133180, 0000133181, 0000134097, 0000134098, 0000137241, 0000137242, 0000138582, 0000138583, 0000139438, 0000139439, 0000139440, 0000139441, 0000140683, 0000140685, 0000140686, 0000140687, 0000146927, 0000146928, 0000147307, 0000150096, 0000150097, 0000150879, 0000150880, 0000150988, 0000152801, 0000152802, 0000152978, 0000153316, 0000153369, 0000157899, 0000158129, 0000158130, 0000158341, 0000158800, 0000159841, 0000159842, 0000161219, 0000161220, 0000162107, 0000162894, 0000166350, 0000166351, 0000166352, 0000166353, 0000170244, 0000172271, 0000172272, 0000172302, 0000172304, 0000172599, 0000172600, 0000172620, 0000172621, 0000173240, 0000173242, 0000174284, 0000174287, 0000174768, 0000174769, 0000175639, 0000175710, 0000175750, 0000176474, 0000176475, 0000176833, 0000176834, 0000177999, 0000178005, 0000180681; M00326310/04546540688743/0000065570, 0000067169, 0000068247, 0000079906, 0000090099, 0000094378, 0000100182, 0000108962, 0000116675, 0000118886, 0000128525, 0000135805, 0000147879, 0000147987, 0000157735, 0000157736; M00326420/04546540688774/0000063779, 0000064566, 0000065241, 0000065646, 0000065762, 0000066263, 0000066472, 0000066582, 0000066989, 0000068096, 0000070222, 0000070864, 0000072031, 0000073134, 0000076285, 0000077556, 0000079694, 0000080326, 0000080455, 0000081868, 0000083175, 0000083952, 0000084099, 0000085613, 0000089328, 0000090670, 0000091905, 0000093818, 0000094819, 0000096587, 0000097110, 0000098541, 0000101652, 0000103036, 0000108815, 0000108961, 0000109973, 0000111204, 0000114401, 0000116311, 0000118674, 0000121398, 0000122490, 0000124885, 0000125790,0000135316, 0000135604, 0000138236, 0000138237, 0000141438, 0000147437, 0000147587, 0000148962, 0000148964, 0000151850, 0000152226, 0000155067, 0000155661, 0000161018, 0000163156, 0000172923, 0000172924, 0000174675, 0000176017, 0000176114, 0000176473, 0000176525; M00326520/04546540688798/0000066684, 0000073892, 0000090098, 0000105762, 0000122738, 0000151278; M00326410/04546540688767/0000063497, 0000063501, 0000063520, 0000063568, 0000063716, 0000063767, 0000063879, 0000063894, 0000063905, 0000063933, 0000064072, 0000064113, 0000064410, 0000064420, 0000064482, 0000064486, 0000064487, 0000064527, 0000064565, 0000064589, 0000064590, 0000064735, 0000064736, 0000064797, 0000064882, 0000064927,0000064960,0000064961, 0000065005, 0000065107, 0000065118, 0000065281, 0000065370, 0000065515, 0000065571, 0000065583, 0000065643, 0000065761, 0000065820, 0000065837, 0000065900, 0000066008, 0000066075, 0000066130, 0000066262, 0000066384, 0000066385, 0000066471,0000066552, 0000066644, 0000066824, 0000066962, 0000067082, 0000067170, 0000067332, 0000067456, 0000067567, 0000067653, 0000067654, 0000067711, 0000067712, 0000067829, 0000068248, 0000068627, 0000069225, 0000069730, 0000069790, 0000069919, 0000070220, 0000070221, 0000070423, 0000070424, 0000070640, 0000070641, 0000071095, 0000071096, 0000071378, 0000072028, 0000072029, 0000072244, 0000072277, 0000073133, 0000073549, 0000073550, 0000074431, 0000074451, 0000075208, 0000075209, 0000075553, 0000075554, 0000075915, 0000076455, 0000077386, 0000077387, 0000077389, 0000077554, 0000077555, 0000078272, 0000078273, 0000078372, 0000079396, 0000080021, 0000080914, 0000081395, 0000081697, 0000081741, 0000081742, 0000082781, 0000082985, 0000082986, 0000083855, 0000083856, 0000085274, 0000085367, 0000085368, 0000085369, 0000085635, 0000085636, 0000085724, 0000085952, 0000086425, 0000086538, 0000086539, 0000086540, 0000086939, 0000086940, 0000087549, 0000087550, 0000087582, 0000087635, 0000088255, 0000088811, 0000088890, 0000089000, 0000089068, 0000089069, 0000089523, 0000090313, 0000090391, 0000090548, 0000090549, 0000091107, 0000091372, 0000091477, 0000091478, 0000091479, 0000092564, 0000092594, 0000092702, 0000092838, 0000093535, 0000093536, 0000094533, 0000094737, 0000094742, 0000094931, 0000094935, 0000095077, 0000095424, 0000095426, 0000095429, 0000095475, 0000095836, 0000095874, 0000096624, 0000096629, 0000096630, 0000096631, 0000096772, 0000096914, 0000097107, 0000097108, 0000097505, 0000097695, 0000097696, 0000097784, 0000097841, 0000097842, 0000099524, 0000099527, 0000099660, 0000100303, 0000100602, 0000100988, 0000101377, 0000101378, 0000101621, 0000101622, 0000101651, 0000102589, 0000102793, 0000102794, 0000102795, 0000102796, 0000103037, 0000103809, 0000104202, 0000104524, 0000104574, 0000104973, 0000104974, 0000105253, 0000105351, 0000105763, 0000105956, 0000105957, 0000106028, 0000106405, 0000106411, 0000106412, 0000107495, 0000107934, 0000107935, 0000108145, 0000108433, 0000108813, 0000109901, 0000110233, 0000110879, 0000110880, 0000111101 ,0000111453, 0000112240, 0000112285, 0000112709, 0000112822, 0000112823, 0000112844, 0000113136, 0000113690, 0000113790, 0000113791, 0000114166, 0000114167, 0000114170, 0000115255, 0000115598, 0000115599, 0000115668 ,0000115669, 0000115670, 0000115926, 0000115927, 0000115965, 0000115966, 0000117044, 0000117679, 0000117830, 0000117831, 0000118137, 0000118138, 0000118202, 0000118415, 0000118416, 0000118675, 0000118804, 0000119600, 0000119601, 0000120211, 0000121051, 0000121106, 0000121215, 0000121216, 0000123073, 0000123148, 0000123149, 0000123406, 0000123493, 0000123526, 0000123527, 0000123983, 0000124070, 0000124158, 0000124159, 0000124212, 0000124213, 0000124629, 0000124630, 0000124637, 0000124638, 0000124846, 0000124847, 0000124848, 0000125413, 0000125417, 0000125696, 0000125717, 0000125718, 0000125788, 0000125789, 0000126853, 0000126923, 0000126924, 0000127370, 0000127371, 0000127750, 0000127751, 0000128386, 0000128387, 0000128524, 0000129626, 0000129628, 0000129839, 0000129840, 0000129900, 0000129901, 0000131302, 0000131303, 0000131335, 0000131336, 0000131720, 0000131721, 0000131722, 0000132105, 0000132106, 0000132107, 0000132150, 0000132151, 0000132152, 0000132739, 0000133393, 0000133394, 0000133846, 0000133847, 0000133931, 0000133932, 0000134092, 0000134093, 0000136250, 0000136251, 0000136411, 0000136412, 0000136676, 0000136677, 0000136918, 0000136919, 0000136922, 0000137320, 0000137321, 0000138750, 0000140167, 0000140175, 0000140308, 0000140564, 0000140568, 0000140977, 0000141439, 0000141440, 0000141441, 0000144374, 0000144831, 0000144832, 0000145094, 0000147187, 0000147188, 0000147383, 0000147438, 0000147439, 0000147588, 0000147983, 0000147984, 0000148347, 0000148348, 0000148349, 0000148350, 0000148351, 0000148889, 0000148892, 0000148963, 0000149417, 0000149418, 0000150098, 0000151282, 0000151283, 0000151284, 0000151382, 0000151383, 0000151679, 0000151849, 0000152229, 0000152374, 0000152519, 0000152520, 0000152521, 0000152800, 0000153607, 0000153694, 0000153695, 0000153972, 0000153984, 0000154307, 0000154308, 0000155015, 0000155066, 0000155069, 0000155663, 0000155664, 0000156793, 0000157431, 0000157433, 0000157434, 0000157890, 0000157891, 0000158805, 0000158806, 0000159540, 0000159993, 0000159995, 0000160373, 0000160380, 0000160381, 0000160432, 0000161017, 0000163717, 0000164441, 0000164660, 0000164661, 0000165475, 0000169345, 0000169346, 0000170245, 0000171218, 0000171219, 0000172527, 0000172529, 0000172530, 0000172863, 0000172864, 0000173164, 0000173935, 0000173936, 0000173937, 0000174288, 0000174291, 0000174352, 0000174353, 0000174372, 0000174404, 0000174405, 0000174406, 0000174407, 0000174408, 0000176115, 0000176117, 0000176118, 0000176329, 0000176330, 0000176827, 0000176828, 0000176829, 0000177034, 0000177035, 0000177078, 0000177079, 0000177080, 0000177521, 0000177527, 0000177533, 0000180797, 0000180798; M00326510/04546540688781/0000063768, 0000063886, 0000064191, 0000064640, 0000065066, 0000066131, 0000066729, 0000066911, 0000067656, 0000067658, 0000067683, 0000068097, 0000069226, 0000069386, 0000069867, 0000070229, 0000070642, 0000071089, 0000073894, 0000074671, 0000075916, 0000077169, 0000077170, 0000078109, 0000079633, 0000081204, 0000081875, 0000081920, 0000082489, 0000083953, 0000084100, 0000086865, 0000087972, 0000089737, 0000090550, 0000091906, 0000093819, 0000094029, 0000094030, 0000097109, 0000097917, 0000099212, 0000101833, 0000102061, 0000103708, 0000105594, 0000107290, 0000109972, 0000111203, 0000111220, 0000114545, 0000116312, 0000116339, 0000118803, 0000118885, 0000121401, 0000121582, 0000121918, 0000124886, 0000126024, 0000126027, 0000134094, 0000135305, 0000139099, 0000139100, 0000142534, 0000146227, 0000146388, 0000146389, 0000146508, 0000146509, 0000150094, 0000150870, 0000152518, 0000152979, 0000153296, 0000153309, 0000156613, 0000157730, 0000158801, 0000160739, 0000163715, 0000164565, 0000170923, 0000170924, 0000170925, 0000173347, 0000173348, 0000173676, 0000173677, 0000174158, 0000174374, 0000175063, 0000177059, 0000177060, 0000177066; S2SPP14215/07613327459654/0000064643, 0000065728, 0000066913, 0000067173, 0000078582, 0000084347, 0000092593, 0000097916, 0000108963, 0000121105, 0000139102, 0000141827, 0000144378, 0000146510, 0000164584; S2SPP14300/07613327459661/0000084348; S2SPS14215/07613327459630/0000064656, 0000065327, 0000065644, 0000067080, 0000067171, 0000067663, 0000068249, 0000072389, 0000084516, 0000084517, 0000091104, 0000095875, 0000100603, 0000103807, 0000109593, 0000113421, 0000114789, 0000118119, 0000121583, 0000122737, 0000125039, 0000126355, 0000128621, 0000139101, 0000141394, 0000143124, 0000143346, 0000147308, 0000176835; S2SPS14300/07613327459647/0000065435, 0000084518, 0000094339, 0000118540, 0000128617, 0000140967, 0000146841

Product

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside…

Recalling firm

Stryker Neurovascular

Quantity

373,246

Distribution

Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.

Recall date

June 12, 2024

Classification

Class II

Status

Ongoing

Agency

FDA (device)