FDA Class II · Medical device · Recall Z-2185-2026 · Recalled May 20, 2026
CS Uni-Directional w Auto ID recall — Stryker Sustainability Solutions Compare identifiers Agency action Open official record ↗ Agency report date: May 20, 2026.
Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
1. Compare your item This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named CS Uni-Directional w Auto ID Company / brand Stryker Sustainability Solutions Lot / serial / date codes 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. Distribution US Nationwide and the countries of Israel and Canada. Agency product description and boundaries CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action FDA reports: Incomplete seals on sterile product
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: CS Uni-Directional w Auto ID recall status
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-2185-2026 Brand All Stryker Sustainability Solutions recalls Classification Class II Units affected 816 units Recall status Ongoing Initiated Voluntary: Firm initiated Affected products Companies & origin Recalling firm location Tempe, AZ, United States Firm address 1810 W Drake Dr, 85283-4327 Identifying details (verbatim from the notice) Product codes / lots 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. Distribution US Nationwide and the countries of Israel and Canada. FDA event ID 98708 Recall initiated April 10, 2026 FDA classified May 13, 2026 FDA report date May 20, 2026 Other medical device recalls from around the same time
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 18, 2026 at 6:00 PM UTC.
Report a data error on this page