CS Uni-Directional w Auto ID 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?

UDI 07613327357318, Lot Numbers: 3351120, 4756053, 4820613, 4880639, 4937971, 4953195, 4974710, 5002528, 5033775, 5067727, 3351123, 4761288, 4821747, 4880648, 4937973, 4953196, 4975470, 5002529, 5033776, 5069585, 3352961, 4764911, 4821750, 4880654, 4937974, 4953197, 4975472, 5002530, 5034566, 5069588, 3369921, 4766954, 4822911, 4880655, 4937975, 4953198, 4975598, 5002531, 5034567, 5069594, 3369925, 4766956, 4824997, 4880656, 4937976, 4953200, 4977751, 5002855, 5034568, 5069597, 3369927, 4767155, 4825261, 4880657, 4937977, 4953201, 4977753, 5003960, 5034569, 5069599, 3369928, 4772390, 4825262, 4880658, 4937982, 4953202, 4977754, 5004190, 5034570, 5069603, 3425440, 4775105, 4825572, 4880938, 4937983, 4953203, 4977768, 5004192, 5034571, 5069606, 3443600, 4786470, 4825573, 4882690, 4937988, 4953204, 4977769, 5004217, 5034572, 5069609, 3444721, 4793099, 4825574, 4882691, 4937992, 4953205, 4977771, 5004219, 5034573, 5071436, 3446184, 4793102, 4825577, 4882693, 4937996, 4953206, 4977773, 5004221, 5034655, 5072106, 3476984, 4793119, 4825814, 4882694, 4938440, 4953338, 4980428, 5005557, 5034903, 5072107, 3485190, 4794754, 4826925, 4882695, 4938441, 4953339, 4980840, 5005558, 5037952, 5072206, 3485192, 4794914, 4826926, 4883802, 4938442, 4953340, 4980841, 5005932, 5037953, 5072407, 3610789, 4795026, 4826927, 4883812, 4940663, 4953341, 4980842, 5005933, 5038342, 5072408, 3662960, 4796837, 4826928, 4883949, 4940850, 4953342, 4980843, 5012759, 5038392, 5072409, 3689125, 4796969, 4826929, 4883950, 4940851, 4953343, 4980844, 5012977, 5038393, 5072410, 3689126, 4797346, 4826930, 4883951, 4941131, 4953344, 4980873, 5014498, 5038394, 5072411, 3697347, 4797347, 4827995, 4883952, 4941133, 4953345, 4980874, 5017458, 5040937, 5072412, 3697352, 4797348, 4827997, 4883953, 4941138, 4955023, 4980875, 5017459, 5040938, 5073110, 3703895, 4797349, 4828183, 4883954, 4941163, 4955024, 4980876, 5017460, 5040939, 5073111, 3703898, 4797351, 4829479, 4890927, 4941164, 4955025, 4980877, 5017461, 5043130, 5073112, 3703899, 4797353, 4830599, 4890957, 4941165, 4960181, 4980878, 5017530, 5043131, 5073113, 3715609, 4797354, 4830791, 4890959, 4941166, 4960193, 4980879, 5017531, 5043134, 5076106, 3715640, 4797356, 4830793, 4890972, 4941167, 4960201, 4980880, 5017532, 5043135, 5076108, 3729296, 4797358, 4830794, 4891905, 4941168, 4960210, 4983266, 5017535, 5043372, 5076109, 3729298, 4797359, 4830991, 4891906, 4941169, 4960224, 4983270, 5017537, 5043681, 5076111, 3976771, 4797363, 4831021, 4891907, 4941170, 4960226, 4983272, 5017538, 5043944, 5076112, 3979774, 4797364, 4833203, 4891908, 4941175, 4960620, 4983284, 5017542, 5044078, 5076115, 4020150, 4797365, 4837752, 4891909, 4941951, 4960725, 4984093, 5019519, 5044079, 5076118, 4022512, 4797876, 4837754, 4891910, 4941953, 4960726, 4984094, 5019520, 5044082, 5076120, 4050955, 4797889, 4837843, 4891911, 4941954, 4960727, 4984097, 5019522, 5044083, 5076121, 4086384, 4798288, 4838883, 4891912, 4941955, 4960728, 4984302, 5019566, 5044084, 5076126, 4086387, 4799276, 4840238, 4891913, 4947436, 4960729, 4985812, 5021631, 5044087, 5076127, 4481221, 4799821, 4841966, 4891914, 4947437, 4961610, 4985815, 5021781, 5044203, 5076128, 4614498, 4800185, 4842013, 4892202, 4947439, 4961611, 4985821, 5021782, 5044204, 5076129, 4614502, 4800186, 4844645, 4896329, 4947440, 4961612, 4985823, 5021819, 5044206, 5076130, 4649179, 4800188, 4845486, 4896330, 4947441, 4961613, 4985824, 5021820, 5044253, 5076131, 4650571, 4800193, 4845490, 4896331, 4947443, 4961614, 4986557, 5021821, 5044261, 5076134, 4663387, 4800194, 4845491, 4896332, 4950355, 4961615, 4987036, 5023691, 5044420, 5082198, 4668855, 4800195, 4847650, 4896333, 4950356, 4961616, 4987393, 5023946, 5044421, 5082202, 4673972, 4800198, 4849977, 4896334, 4950549, 4961617, 4987587, 5025606, 5045183, 5082205, 4726087, 4800199, 4850105, 4896419, 4950553, 4962190, 4990610, 5025607, 5045185, 5082207, 4726095, 4800200, 4850107, 4896421, 4953131, 4962191, 4990820, 5025608, 5045186, 5082209, 4726096, 4800204, 4853343, 4896422, 4953133, 4962981, 4990821, 5025724, 5045891, 5082211, 4726103, 4800206, 4854412, 4896423, 4953134, 4962982, 4990822, 5025725, 5052613, 5082212, 4726780, 4800279, 4855363, 4896424, 4953136, 4963015, 4992270, 5025727, 5052614, 5082213, 4728807, 4800874, 4855364, 4897428, 4953137, 4963016, 4993094, 5025728, 5052615, 5082214, 4728839, 4800876, 4855367, 4937750, 4953138, 4963017, 4993095, 5025729, 5053557, 5082215, 4729213, 4800877, 4855666, 4937754, 4953139, 4963040, 4993096, 5025895, 5053558, 5082216, 4730622, 4801737, 4856278, 4937757, 4953140, 4963308, 4993111, 5025912, 5053559, 5082217, 4730634, 4801959, 4859383, 4937759, 4953142, 4963309, 4993119, 5025919, 5053560, 5082218, 4731318, 4802512, 4859384, 4937760, 4953144, 4963310, 4993226, 5026193, 5053561, 5083460, 4731328, 4802614, 4859413, 4937763, 4953145, 4966247, 4993227, 5026194, 5054082, 5085972, 4732001, 4802815, 4859417, 4937769, 4953146, 4966248, 4993228, 5026692, 5056201, 5085973, 4733531, 4802925, 4859709, 4937836, 4953147, 4968799, 4994012, 5026693, 5056202, 5086369, 4734479, 4803529, 4860609, 4937837, 4953148, 4972869, 4994080, 5026832, 5056203, 5086371, 4735289, 4803533, 4861443, 4937838, 4953169, 4972872, 4994803, 5029136, 5056848, 5086372, 4736363, 4803808, 4864439, 4937839, 4953171, 4973398, 4994860, 5029137, 5057349, 5086373, 4737394, 4804041, 4864848, 4937840, 4953173, 4973417, 4994863, 5032245, 5058020, 5086374, 4738377, 4806961, 4864851, 4937841, 4953176, 4973418, 4994866, 5032246, 5058021, 5086376, 4738390, 4807448, 4864875, 4937847, 4953177, 4973421, 4998169, 5033410, 5059047, 5086377, 4738391, 4807605, 4864876, 4937848, 4953178, 4973426, 4998170, 5033412, 5059077, 5086379, 4738395, 4807717, 4864877, 4937851, 4953179, 4973427, 4998947, 5033591, 5059078, 5086380, 4739012, 4807718, 4867552, 4937854, 4953180, 4973430, 4998948, 5033619, 5061477, 5086521, 4741793, 4814727, 4867805, 4937855, 4953185, 4973463, 4998950, 5033620, 5061478, 5086522, 4741794, 4818092, 4868856, 4937856, 4953186, 4973465, 4998951, 5033621, 5061479, 5086523, 4749251, 4818093, 4869232, 4937857, 4953188, 4973466, 4998952, 5033622, 5061480, 5086525, 4749265, 4818095, 4870634, 4937858, 4953190, 4973468, 4998953, 5033623, 5061481, 5086526, 4749373, 4818194, 4876110, 4937859, 4953191, 4973470, 4999004, 5033624, 5062616, 5086539, 4749406, 4820176, 4877011, 4937863, 4953192, 4973476, 4999893, 5033625, 5062617, 5086666, 4749796, 4820610, 4880527, 4937865, 4953193, 4973858, 5002388, 5033773, 5062618, 5086667, 4755379, 4820611, 4880638, 4937868, 4953194, 4974111, 5002527, 5033774, 5066983.

Product

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Recalling firm

Stryker Sustainability Solutions

Quantity

816 units

Distribution

US Nationwide and the countries of Israel and Canada.

Recall date

May 20, 2026

Classification

Class II

Status

Ongoing

Agency

FDA (device)