FDAClass II · Medical device · Recall Z-2191-2026 · Recalled May 20, 2026
Daig Livewire Steerable recall — Stryker Sustainability Solutions
Agency report date: May 20, 2026.
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
- Daig Livewire Steerable
- Company / brand
- Stryker Sustainability Solutions
- Lot / serial / date codes
- UDI 00885825007263, Lot Numbers: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232, 3481897, 4488631, 4592566, 4802770, 4882750, 4967857, 4993023, 5005187, 5043930, 5071390, 3625879, 4488632, 4592567, 4804079, 4882752, 4967858, 4993039, 5005189, 5043931, 5071391, 3839101, 4488634, 4592569, 4807663, 4882753, 4968857, 4993040, 5005332, 5043932, 5071455, 3957393, 4488637, 4592570, 4807753, 4882754, 4968859, 4993322, 5005666, 5043985, 5071456, 3969685, 4488639, 4592571, 4807830, 4882758, 4968860, 4993327, 5005943, 5043986, 5071458, 3969688, 4488714, 4593641, 4808039, 4883012, 4968861, 4993563, 5005944, 5043988, 5071963, 3969689, 4488715, 4593648, 4808040, 4883125, 4968862, 4993564, 5008502, 5043990, 5071964, 3969691, 4488739, 4593688, 4808043, 4883516, 4968863, 4993567, 5009554, 5044183, 5071999, 3997894, 4488740, 4593691, 4808044, 4883867, 4969223, 4993568, 5009555, 5044426, 5072263, 4033681, 4488741, 4600193, 4808744, 4883868, 4971027, 4993570, 5011420, 5044427, 5072264, 4077276, 4488742, 4600447, 4808745, 4883869, 4971028, 4993663, 5011445, 5044428, 5073606, 4077953, 4488743, 4600448, 4808847, 4883873, 4971029, 4993665, 5011448, 5044452, 5074725, 4078768, 4489056, 4600449, 4809125, 4883874, 4971031, 4993667, 5012682, 5044492, 5074790, 4084962, 4489057, 4600450, 4809535, 4884126, 4971040, 4993668, 5012713, 5044493, 5074792, 4088602, 4490459, 4600471, 4810430, 4884403, 4971789, 4993688, 5012715, 5044559, 5074794, 4090290, 4492749, 4600568, 4814762, 4884404, 4971972, 4994217, 5012716, 5044560, 5074795, 4094954, 4493075, 4600570, 4816437, 4884657, 4971973, 4994544, 5012725, 5044688, 5075340, 4103537, 4493153, 4600571, 4820371, 4884661, 4971975, 4994545, 5012769, 5044722, 5075341, 4106220, 4495359, 4600572, 4822199, 4890810, 4972079, 4994547, 5012882, 5044724, 5075342, 4109694, 4496631, 4601552, 4822200, 4890812, 4972081, 4994746, 5013185, 5044925, 5075604, 4121179, 4496710, 4601553, 4822203, 4891072, 4972082, 4994806, 5013186, 5045266, 5075605, 4121180, 4500503, 4601557, 4822204, 4895189, 4972221, 4994807, 5013187, 5045290, 5075611, 4121185, 4502646, 4601799, 4822695, 4896278, 4972222, 4994808, 5013236, 5045778, 5076450, 4125751, 4502650, 4601800, 4823914, 4896279, 4972224, 4994809, 5013238, 5045867, 5076501, 4137020, 4502651, 4601801, 4823932, 4896280, 4972264, 4994810, 5014318, 5045871, 5076936, 4138259, 4502658, 4601803, 4823966, 4896288, 4972468, 4994811, 5014910, 5050052, 5079203, 4145477, 4503630, 4601895, 4825821, 4896344, 4972572, 4994812, 5014913, 5050053, 5079234, 4147774, 4503898, 4601896, 4825822, 4896345, 4972574, 4994813, 5015403, 5050723, 5080077, 4150717, 4504009, 4601933, 4825825, 4938073, 4973258, 4994815, 5016467, 5050724, 5080137, 4153615, 4504010, 4602051, 4827080, 4938369, 4974331, 4996486, 5016468, 5050725, 5080138, 4163839, 4504011, 4602052, 4827081, 4938370, 4974355, 4996487, 5016551, 5050772, 5080226, 4174407, 4504012, 4602069, 4827580, 4939088, 4974396, 4997782, 5016564, 5050774, 5080229, 4174732, 4504013, 4602072, 4827641, 4939089, 4976505, 4997784, 5017311, 5050777, 5080231, 4184158, 4504014, 4602261, 4828176, 4940070, 4976790, 4997785, 5017313, 5050778, 5080232, 4186230, 4504016, 4602264, 4828398, 4940074, 4978152, 4997818, 5017488, 5051585, 5080233, 4193302, 4504017, 4602265, 4830884, 4940075, 4979643, 4997819, 5017506, 5051588, 5080234, 4200073, 4504018, 4602266, 4830888, 4940164, 4980508, 4997820, 5017507, 5053161, 5080235, 4209050, 4504058, 4602268, 4830894, 4940165, 4980580, 4997821, 5018517, 5055341, 5080236, 4214440, 4504059, 4602269, 4831543, 4940167, 4980582, 4997822, 5021602, 5055562, 5080237, 4218216, 4504106, 4602272, 4831637, 4940168, 4980583, 4997823, 5021603, 5055563, 5080239, 4221872, 4504109, 4602391, 4831749, 4940169, 4980584, 4997955, 5021616, 5055565, 5080690, 4230877, 4504111, 4602392, 4832594, 4940170, 4980585, 4997968, 5021921, 5055566, 5080691, 4251024, 4504112, 4602394, 4832618, 4940445, 4980644, 4998106, 5021924, 5055567, 5080693, 4257655, 4504126, 4602396, 4832645, 4940571, 4980646, 4998107, 5021959, 5055568, 5080921, 4261136, 4504145, 4603771, 4833087, 4940616, 4980650, 4998124, 5022503, 5055856, 5081256, 4261989, 4504399, 4605057, 4833521, 4940619, 4980652, 4998126, 5022504, 5055857, 5081257, 4269978, 4504618, 4605171, 4833557, 4940705, 4980653, 4998144, 5022509, 5056078, 5081259, 4277172, 4504620, 4605325, 4835239, 4940708, 4980938, 4998163, 5022510, 5056079, 5081336, 4278364, 4504621, 4606291, 4835251, 4940710, 4981019, 4998199, 5022511, 5056091, 5081337, 4278379, 4504622, 4607158, 4835261, 4940750, 4981067, 4998200, 5022516, 5056099, 5081429, 4279434, 4504853, 4607160, 4836079, 4945389, 4981105, 4998201, 5022519, 5056171, 5081430, 4280364, 4505760, 4610155, 4838321, 4945391, 4981120, 4998202, 5022999, 5056173, 5081431, 4280559, 4505764, 4612417, 4838856, 4945960, 4981121, 4998203, 5023004, 5056530, 5081432, 4289469, 4505916, 4615355, 4838858, 4946261, 4981334, 4998312, 5023594, 5056531, 5081433, 4289916, 4505918, 4616893, 4841186, 4946297, 4981335, 4998314, 5023765, 5056532, 5081434, 4293151, 4505923, 4620831, 4845212, 4946329, 4981336, 4998315, 5025552, 5056533, 5081435, 4293191, 4506161, 4627345, 4846488, 4946334, 4981339, 4998316, 5026161, 5056583, 5081436, 4297312, 4508716, 4628305, 4846957, 4946820, 4981361, 4998317, 5027865, 5056942, 5081437, 4303310, 4509241, 4634939, 4849110, 4946861, 4982396, 4998318, 5028446, 5056946, 5082130, 4309841, 4510678, 4636756, 4850085, 4946870, 4982481, 4998319, 5029004, 5056947, 5082131, 4314656, 4514999, 4651368, 4850178, 4946871, 4986049, 4998463, 5029005, 5057030, 5082132, 4332418, 4517299, 4651951, 4851046, 4946872, 4986051, 4998553, 5029006, 5057040, 5082133, 4336480, 4518638, 4659503, 4851121, 4947806, 4986176, 4998555, 5029007, 5057041, 5082162, 4346630, 4520727, 4670710, 4851737, 4948144, 4986177, 4998675, 5029100, 5057681, 5082163, 4360500, 4522377, 4690071, 4851781, 4948145, 4986181, 4998676, 5029104, 5057684, 5082165, 4374689, 4523461, 4690072, 4852958, 4948394, 4986183, 4998677, 5029394, 5058317, 5082186, 4376375, 4527966, 4723938, 4853149, 4948842, 4986184, 4998678, 5029399, 5059532, 5082436, 4391398, 4528992, 4730817, 4853205, 4950172, 4986209, 4998680, 5030070, 5059533, 5082437, 4391622, 4528993, 4733822, 4854052, 4950205, 4986397, 4998724, 5030260, 5059534, 5082485, 4394982, 4528994, 4733944, 4854058, 4950206, 4986398, 4998726, 5030906, 5059805, 5082523, 4405424, 4529570, 4741229, 4854093, 4950219, 4986401, 4998727, 5032117, 5060187, 5082524, 4424448, 4529571, 4741802, 4854094, 4950221, 4986402, 4998728, 5032118, 5060188, 5082526, 4427527, 4529575, 4741958, 4854096, 4950444, 4986405, 4998756, 5032119, 5060531, 5082529, 4427528, 4529576, 4745701, 4854775, 4950445, 4986415, 4998976, 5032120, 5060576, 5084996, 4446511, 4529579, 4745705, 4854782, 4950566, 4986417, 4998979, 5032211, 5060577, 5085164, 4450119, 4529916, 4747168, 4856267, 4950583, 4986513, 4999001, 5032212, 5061346, 5085168, 4451525, 4532537, 4747169, 4857148, 4950602, 4986517, 4999002, 5032213, 5061347, 5085186, 4454440, 4535712, 4747911, 4860073, 4951016, 4986518, 4999005, 5032216, 5061350, 5085191, 4456551, 4537043, 4747915, 4860426, 4952556, 4986543, 4999006, 5032218, 5062604, 5085192, 4457631, 4537240, 4747922, 4861413, 4952558, 4986544, 4999007, 5032220, 5062606, 5085329, 4459426, 4538745, 4750810, 4861417, 4952572, 4986545, 4999008, 5032222, 5062699, 5085330, 4460845, 4539769, 4751072, 4861548, 4952644, 4986579, 4999009, 5032342, 5062714, 5085407, 4461247, 4539777, 4751737, 4863489, 4952767, 4986940, 4999010, 5032347, 5062717, 5086017, 4461249, 4539916, 4752002, 4863490, 4953263, 4986951, 4999011, 5032436, 5062719, 5086028, 4464145, 4539917, 4752039, 4864134, 4953988, 4986952, 4999243, 5033806, 5062725, 5086029, 4464213, 4539918, 4752413, 4865011, 4953991, 4987186, 4999246, 5033812, 5062884, 5086030, 4464886, 4539921, 4752639, 4865117, 4953992, 4987267, 4999434, 5033923, 5062886, 5086422, 4468713, 4539922, 4753626, 4865743, 4953995, 4987410, 4999435, 5033924, 5062888, 5086423, 4468717, 4539933, 4754842, 4866620, 4954212, 4987411, 4999446, 5034216, 5062890, 5086461, 4468718, 4539934, 4755006, 4868327, 4954701, 4987412, 4999447, 5034217, 5063915, 5086465, 4471823, 4539941, 4756536, 4868499, 4960641, 4987413, 4999448, 5034219, 5063925, 5086466, 4472663, 4540608, 4758867, 4868500, 4960642, 4987427, 4999449, 5034222, 5063927, 5086467, 4472845, 4540967, 4759474, 4870588, 4960844, 4987451, 4999517, 5034233, 5063930, 5086469, 4474029, 4540975, 4766366, 4870592, 4960845, 4987454, 4999518, 5034316, 5063934, 5086470, 4475511, 4540976, 4766380, 4870595, 4960846, 4987455, 4999521, 5034364, 5063936, 5086472, 4476441, 4540979, 4768458, 4872695, 4960847, 4987485, 4999734, 5034365, 5063940, 5086474, 4477344, 4540983, 4768459, 4872697, 4960851, 4990719, 4999735, 5034366, 5063942, 5086475, 4478315, 4540985, 4771188, 4872698, 4960852, 4990768, 4999736, 5034383, 5063945, 5087201, 4478461, 4541073, 4772924, 4874524, 4961048, 4990826, 4999749, 5034494, 5063947, 5087202, 4480952, 4542502, 4773466, 4875169, 4961050, 4990888, 4999750, 5034499, 5063971, 5087314, 4480954, 4543055, 4773474, 4875170, 4961053, 4990892, 4999752, 5035029, 5064724, 5087324, 4480956, 4543929, 4775580, 4875171, 4961055, 4991110, 4999753, 5037372, 5064727, 5087325, 4480957, 4546972, 4785008, 4875410, 4961056, 4991112, 4999898, 5037374, 5064730, 4480958, 4547001, 4787592, 4875583, 4961057, 4991115, 4999899, 5041080, 5064733, 4480959, 4547059, 4787593, 4876190, 4961058, 4991471, 4999904, 5041956, 5067018, 4480960, 4549921, 4792674, 4876356, 4961060, 4991486, 4999963, 5041957, 5067019, 4480961, 4555833, 4793241, 4876357, 4961061, 4991487, 4999964, 5042466, 5067146, 4480962, 4559848, 4793246, 4880502, 4961592, 4991488, 4999966, 5042979, 5067148, 4481267, 4563467, 4793386, 4880506, 4961593, 4992172, 4999980, 5042980, 5067149, 4483538, 4563581, 4793439, 4880774, 4961594, 4992173, 4999981, 5042988, 5067150, 4484859, 4566874, 4793872, 4880775, 4961595, 4992188, 5001925, 5043248, 5067151, 4484978, 4566875, 4793876, 4880776, 4961631, 4992241, 5002260, 5043382, 5067192, 4484979, 4570915, 4796383, 4880777, 4961660, 4992242, 5002263, 5043519, 5067193, 4484980, 4571160, 4796960, 4880975, 4961683, 4992465, 5002274, 5043520, 5067194, 4484981, 4573719, 4798005, 4880976, 4961704, 4992589, 5002347, 5043526, 5067195, 4485739, 4579535, 4798190, 4880977, 4961757, 4992763, 5002403, 5043529, 5067196, 4486132, 4579743, 4798645, 4881115, 4961758, 4992764, 5002473, 5043532, 5067335, 4487531, 4583398, 4799273, 4881301, 4961761, 4992765, 5002474, 5043533, 5067337, 4487542, 4584255, 4799345, 4881302, 4962989, 4992897, 5002599, 5043843, 5068387, 4487543, 4584451, 4799438, 4882554, 4962992, 4992899, 5002600, 5043854, 5068971, 4488471, 4584464, 4799852, 4882556, 4962999, 4992959, 5002601, 5043855, 5068973, 4488472, 4587013, 4800147, 4882557, 4963001, 4992961, 5004950, 5043856, 5068974, 4488473, 4589702, 4801080, 4882563, 4963211, 4992969, 5004970, 5043857, 5069379, 4488474, 4591788, 4801479, 4882564, 4963421, 4992970, 5004973, 5043858, 5071210, 4488475, 4591947, 4801481, 4882590, 4963426, 4992974, 5004975, 5043859, 5071211, 4488620, 4591951, 4801482, 4882600, 4967855, 4993018, 5004977, 5043928, 5071213.
- Distribution
- US Nationwide and the countries of Israel and Canada.
Agency product description and boundaries
Daig Livewire Steerable, Product Number 401904; 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: Daig Livewire Steerable recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2191-2026
- Brand
- All Stryker Sustainability Solutions recalls
- Classification
- Class II
- Units affected
- 1352 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 00885825007263, Lot Numbers: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232, 3481897, 4488631, 4592566, 4802770, 4882750, 4967857, 4993023, 5005187, 5043930, 5071390, 3625879, 4488632, 4592567, 4804079, 4882752, 4967858, 4993039, 5005189, 5043931, 5071391, 3839101, 4488634, 4592569, 4807663, 4882753, 4968857, 4993040, 5005332, 5043932, 5071455, 3957393, 4488637, 4592570, 4807753, 4882754, 4968859, 4993322, 5005666, 5043985, 5071456, 3969685, 4488639, 4592571, 4807830, 4882758, 4968860, 4993327, 5005943, 5043986, 5071458, 3969688, 4488714, 4593641, 4808039, 4883012, 4968861, 4993563, 5005944, 5043988, 5071963, 3969689, 4488715, 4593648, 4808040, 4883125, 4968862, 4993564, 5008502, 5043990, 5071964, 3969691, 4488739, 4593688, 4808043, 4883516, 4968863, 4993567, 5009554, 5044183, 5071999, 3997894, 4488740, 4593691, 4808044, 4883867, 4969223, 4993568, 5009555, 5044426, 5072263, 4033681, 4488741, 4600193, 4808744, 4883868, 4971027, 4993570, 5011420, 5044427, 5072264, 4077276, 4488742, 4600447, 4808745, 4883869, 4971028, 4993663, 5011445, 5044428, 5073606, 4077953, 4488743, 4600448, 4808847, 4883873, 4971029, 4993665, 5011448, 5044452, 5074725, 4078768, 4489056, 4600449, 4809125, 4883874, 4971031, 4993667, 5012682, 5044492, 5074790, 4084962, 4489057, 4600450, 4809535, 4884126, 4971040, 4993668, 5012713, 5044493, 5074792, 4088602, 4490459, 4600471, 4810430, 4884403, 4971789, 4993688, 5012715, 5044559, 5074794, 4090290, 4492749, 4600568, 4814762, 4884404, 4971972, 4994217, 5012716, 5044560, 5074795, 4094954, 4493075, 4600570, 4816437, 4884657, 4971973, 4994544, 5012725, 5044688, 5075340, 4103537, 4493153, 4600571, 4820371, 4884661, 4971975, 4994545, 5012769, 5044722, 5075341, 4106220, 4495359, 4600572, 4822199, 4890810, 4972079, 4994547, 5012882, 5044724, 5075342, 4109694, 4496631, 4601552, 4822200, 4890812, 4972081, 4994746, 5013185, 5044925, 5075604, 4121179, 4496710, 4601553, 4822203, 4891072, 4972082, 4994806, 5013186, 5045266, 5075605, 4121180, 4500503, 4601557, 4822204, 4895189, 4972221, 4994807, 5013187, 5045290, 5075611, 4121185, 4502646, 4601799, 4822695, 4896278, 4972222, 4994808, 5013236, 5045778, 5076450, 4125751, 4502650, 4601800, 4823914, 4896279, 4972224, 4994809, 5013238, 5045867, 5076501, 4137020, 4502651, 4601801, 4823932, 4896280, 4972264, 4994810, 5014318, 5045871, 5076936, 4138259, 4502658, 4601803, 4823966, 4896288, 4972468, 4994811, 5014910, 5050052, 5079203, 4145477, 4503630, 4601895, 4825821, 4896344, 4972572, 4994812, 5014913, 5050053, 5079234, 4147774, 4503898, 4601896, 4825822, 4896345, 4972574, 4994813, 5015403, 5050723, 5080077, 4150717, 4504009, 4601933, 4825825, 4938073, 4973258, 4994815, 5016467, 5050724, 5080137, 4153615, 4504010, 4602051, 4827080, 4938369, 4974331, 4996486, 5016468, 5050725, 5080138, 4163839, 4504011, 4602052, 4827081, 4938370, 4974355, 4996487, 5016551, 5050772, 5080226, 4174407, 4504012, 4602069, 4827580, 4939088, 4974396, 4997782, 5016564, 5050774, 5080229, 4174732, 4504013, 4602072, 4827641, 4939089, 4976505, 4997784, 5017311, 5050777, 5080231, 4184158, 4504014, 4602261, 4828176, 4940070, 4976790, 4997785, 5017313, 5050778, 5080232, 4186230, 4504016, 4602264, 4828398, 4940074, 4978152, 4997818, 5017488, 5051585, 5080233, 4193302, 4504017, 4602265, 4830884, 4940075, 4979643, 4997819, 5017506, 5051588, 5080234, 4200073, 4504018, 4602266, 4830888, 4940164, 4980508, 4997820, 5017507, 5053161, 5080235, 4209050, 4504058, 4602268, 4830894, 4940165, 4980580, 4997821, 5018517, 5055341, 5080236, 4214440, 4504059, 4602269, 4831543, 4940167, 4980582, 4997822, 5021602, 5055562, 5080237, 4218216, 4504106, 4602272, 4831637, 4940168, 4980583, 4997823, 5021603, 5055563, 5080239, 4221872, 4504109, 4602391, 4831749, 4940169, 4980584, 4997955, 5021616, 5055565, 5080690, 4230877, 4504111, 4602392, 4832594, 4940170, 4980585, 4997968, 5021921, 5055566, 5080691, 4251024, 4504112, 4602394, 4832618, 4940445, 4980644, 4998106, 5021924, 5055567, 5080693, 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- 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
Related recalls
Other medical device recalls from around the same time
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- RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.FDA · June 3, 2026
- NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
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- Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
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.