FDA event 98708 · Recall Observatory

device · product 1 of 26

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2174-2026

Recall number: Z-2174-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 3063 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

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4390050, 4518897, 4614279, 4768965, 4869403, 4972073, 5018644, 5072229, 4049071, 4267742, 4391287, 4519350, 4614412, 4768966, 4869406, 4972075, 5019470, 5072230, 4055039, 4267768, 4391288, 4521754, 4615324, 4769573, 4869410, 4972076, 5020472, 5072249, 4058659, 4268205, 4391291, 4522756, 4616725, 4774326, 4869412, 4972077, 5020894, 5072251, 4059926, 4268207, 4391293, 4522813, 4616726, 4774950, 4869413, 4972456, 5021877, 5073507, 4059934, 4271745, 4391295, 4523028, 4616732, 4774951, 4869416, 4972457, 5021980, 5073508, 4061921, 4272128, 4391296, 4523343, 4617007, 4775225, 4869423, 4972912, 5022497, 5076613, 4062655, 4272969, 4391297, 4529564, 4618021, 4775919, 4870259, 4972915, 5022499, 5076615, 4066543, 4272972, 4391298, 4529664, 4618022, 4776776, 4871287, 4972916, 5022971, 5076616, 4066544, 4273081, 4391299, 4529667, 4618028, 4777201, 4871292, 4972918, 5022972, 5076678, 4066664, 4273094, 4392411, 4530387, 4618031, 4777208, 4871294, 4972919, 5022976, 5076681, 4066665, 4273506, 4392455, 4531012, 4618032, 4777265, 4871619, 4972921, 5023249, 5076928, 4066875, 4274072, 4392759, 4536235, 4618034, 4777557, 4871724, 4972924, 5023251, 5077725, 4066895, 4274175, 4392961, 4537815, 4618038, 4777872, 4871745, 4972936, 5023252, 5080178, 4066897, 4275121, 4392962, 4538569, 4618043, 4780122, 4873198, 4972937, 5023253, 5080179, 4066898, 4275409, 4393026, 4538629, 4618063, 4781657, 4873200, 4972938, 5023257, 5080180, 4066899, 4275411, 4393547, 4538630, 4619052, 4781680, 4873201, 4972939, 5023258, 5080181, 4066900, 4275560, 4393830, 4538635, 4619094, 4784899, 4873202, 4973654, 5023259, 5080182, 4066901, 4275628, 4395013, 4545279, 4619753, 4785760, 4873203, 4973689, 5023260, 5080268, 4066902, 4275637, 4395474, 4545291, 4619813, 4785902, 4873204, 4973690, 5023261, 5080269, 4066903, 4275639, 4396681, 4546478, 4619883, 4786811, 4873205, 4973694, 5023262, 5080270, 4069700, 4275640, 4396683, 4548505, 4619884, 4787289, 4873208, 4973800, 5023268, 5080317, 4071120, 4275646, 4396768, 4548900, 4621767, 4789907, 4873210, 4973803, 5023269, 5080318, 4071122, 4275977, 4396773, 4548924, 4621768, 4789908, 4873238, 4973843, 5023270, 5080319, 4071206, 4276090, 4396778, 4548925, 4624635, 4789912, 4873241, 4973905, 5023271, 5080320, 4071224, 4276091, 4397180, 4548928, 4624694, 4789913, 4873244, 4974063, 5023272, 5080321, 4071238, 4276096, 4397576, 4548930, 4624697, 4789916, 4873245, 4974090, 5023274, 5080793, 4071239, 4276629, 4397985, 4548932, 4624704, 4789917, 4873246, 4974102, 5023275, 5080867, 4074807, 4276705, 4399560, 4548934, 4625039, 4792633, 4873248, 4974405, 5023277, 5080868, 4074808, 4278355, 4400379, 4548936, 4625040, 4792642, 4873249, 4974423, 5023347, 5080869, 4077436, 4278356, 4401429, 4548937, 4625086, 4792781, 4873251, 4974514, 5023917, 5080870, 4077448, 4278485, 4401561, 4548958, 4625088, 4792996, 4873252, 4974528, 5024343, 5080871, 4077449, 4278489, 4401750, 4549015, 4628269, 4793053, 4873255, 4974741, 5025462, 5080931, 4085793, 4278491, 4402535, 4549023, 4628509, 4793227, 4873258, 4975447, 5025470, 5080951, 4085796, 4278494, 4403414, 4549031, 4628531, 4793669, 4873259, 4975508, 5025701, 5081390, 4085855, 4278537, 4405288, 4549032, 4628553, 4793670, 4873261, 4975509, 5025702, 5082234, 4085908, 4278538, 4405292, 4549035, 4629102, 4793681, 4873262, 4975526, 5026065, 5082235, 4085910, 4278684, 4405448, 4549036, 4629103, 4794120, 4873263, 4976224, 5026066, 5082236, 4088864, 4278687, 4407183, 4549040, 4630515, 4795263, 4873264, 4976573, 5029154, 5082288, 4088868, 4279463, 4408885, 4549045, 4632167, 4796282, 4873266, 4976576, 5029155, 5082289, 4090869, 4279660, 4408887, 4549340, 4632592, 4798039, 4873268, 4976768, 5029156, 5082290, 4092529, 4281214, 4409092, 4549341, 4635227, 4798040, 4873275, 4978077, 5029157, 5082603, 4095331, 4281414, 4409238, 4549391, 4636021, 4798041, 4873380, 4979490, 5029158, 5082604, 4097283, 4281418, 4409779, 4549393, 4636988, 4799880, 4873381, 4979491, 5029159, 5082605, 4097285, 4281484, 4409787, 4549394, 4637061, 4799881, 4873383, 4979524, 5029160, 5082606, 4097420, 4281486, 4414755, 4549395, 4639897, 4800785, 4873384, 4980342, 5029161, 5082607, 4097432, 4281487, 4416110, 4549396, 4640280, 4800786, 4873385, 4980395, 5029332, 5082608, 4097925, 4281686, 4416112, 4549401, 4640281, 4801194, 4873389, 4980396, 5029344, 5082609, 4097954, 4281687, 4416201, 4549402, 4640286, 4801431, 4873390, 4980488, 5029345, 5082700, 4101672, 4281690, 4416325, 4549410, 4642583, 4801433, 4873394, 4980547, 5029346, 5082736, 4104592, 4281691, 4417573, 4549567, 4643000, 4801545, 4873395, 4980548, 5029347, 5082737, 4107161, 4282195, 4419066, 4549572, 4643004, 4801546, 4874870, 4980549, 5029348, 5082738, 4114293, 4282507, 4420950, 4549580, 4643009, 4801547, 4874875, 4980550, 5029350, 5082829, 4117262, 4282508, 4421186, 4549638, 4643215, 4802583, 4874876, 4980551, 5029385, 5082830, 4118063, 4282509, 4422970, 4549639, 4643234, 4803716, 4875131, 4980552, 5029386, 5082831, 4119112, 4283949, 4423404, 4549949, 4643772, 4803941, 4877580, 4980553, 5029594, 5083010, 4119145, 4284418, 4429526, 4549968, 4643794, 4803942, 4877630, 4980667, 5029596, 5084997, 4120326, 4284419, 4430848, 4550019, 4644117, 4803957, 4877715, 4980924, 5029696, 5084998, 4120919, 4284563, 4431139, 4550020, 4644118, 4803962, 4881060, 4980927, 5029697, 5085000, 4122413, 4284661, 4431886, 4552311, 4644126, 4804063, 4881061, 4981085, 5030129, 5085002, 4129794, 4285698, 4432706, 4552656, 4644683, 4804066, 4881062, 4981114, 5030133, 5085196, 4129851, 4287101, 4435856, 4556997, 4645718, 4804067, 4881063, 4981115, 5030323, 5085364, 4130695, 4287203, 4437858, 4559158, 4645724, 4806913, 4881066, 4981357, 5030324, 5085365, 4134313, 4287575, 4438456, 4559160, 4646683, 4808345, 4881067, 4981358, 5030394, 5085412, 4134411, 4290332, 4441303, 4559161, 4646686, 4808346, 4881068, 4981392, 5030971, 5085917, 4137980, 4290334, 4441306, 4559162, 4648006, 4808347, 4881099, 4981393, 5030974, 5085918, 4138643, 4293260, 4446555, 4559163, 4649196, 4808704, 4881100, 4981394, 5030975, 5085919, 4139564, 4294899, 4446698, 4559164, 4649400, 4808705, 4881101, 4981395, 5032083, 5085920, 4140948, 4294971, 4446891, 4559165, 4649402, 4808728, 4881102, 4981396, 5032084, 5085921, 4143012, 4297980, 4448121, 4559166, 4650553, 4808729, 4881103, 4981397, 5032085, 5085999, 4144717, 4298560, 4450634, 4559168, 4651678, 4808859, 4881104, 4981398, 5032086, 5086005, 4145567, 4299631, 4451314, 4559171, 4652041, 4810414, 4881105, 4981399, 5032087, 5086006, 4147788, 4300369, 4452132, 4559566, 4652047, 4812023, 4881106, 4983497, 5032088, 5086509, 4147883, 4300370, 4454475, 4559567, 4652050, 4813664, 4881107, 4983776, 5032103, 5086510, 4147887, 4300701, 4455033, 4559568, 4655092, 4813667, 4881108, 4984641, 5032104, 5086511, 4148802, 4300726, 4455039, 4559835, 4655625, 4813669, 4881109, 4984797, 5032163, 5086512, 4149227, 4302668, 4455040, 4559836, 4656012, 4813671, 4881254, 4986193, 5032164, 5086711, 4149969, 4303896, 4455168, 4559837, 4656013, 4813770, 4881440, 4986194, 5032187, 5086717, 4150815, 4303903, 4455169, 4559890, 4656020, 4814782, 4881442, 4986195, 5032188, 5086720, 4150816, 4304007, 4456588, 4559892, 4656023, 4814791, 4881453, 4986546, 5032369, 4152114, 4304318, 4456589, 4559941, 4656112, 4814850, 4881454, 4986547, 5032370, 4153497, 4304319, 4456591, 4559942, 4656116, 4815412, 4881455, 4986548, 5032387, 4153504, 4304355, 4457636, 4559943, 4656119, 4815413, 4881457, 4986565, 5032388, 4154957, 4304924, 4457638, 4559944, 4658880, 4815457, 4881458, 4986566, 5032389, 4155772, 4305035, 4457639, 4559946, 4658881, 4815460, 4881593, 4987016, 5032934.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 2 of 26

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2175-2026

Recall number: Z-2175-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 3 of 26

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2176-2026

Recall number: Z-2176-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 4 of 26

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Z-2177-2026

Recall number: Z-2177-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 427 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825005528, Lot Numbers: 3495675, 4117216, 4330131, 4471121, 4553575, 4630179, 4768595, 4821705, 4954755, 5043512, 3684287, 4129638, 4334639, 4471122, 4554838, 4630180, 4773075, 4821706, 4954759, 5043513, 3691298, 4145046, 4334644, 4474949, 4555860, 4634858, 4793018, 4821707, 4961661, 5043514, 3763763, 4150788, 4334650, 4474951, 4556028, 4634859, 4793019, 4821708, 4971101, 5043515, 3775492, 4175981, 4355098, 4474952, 4569198, 4634860, 4793020, 4822439, 4971102, 5043518, 3775494, 4179878, 4359156, 4479369, 4569199, 4635785, 4793021, 4822440, 4973758, 5045769, 3784070, 4184227, 4359191, 4479371, 4569215, 4635862, 4793022, 4822455, 4974714, 5045901, 3792331, 4186482, 4359418, 4483403, 4570262, 4640440, 4794757, 4830178, 4976272, 5050564, 3794912, 4188323, 4367362, 4483440, 4576849, 4640444, 4794787, 4830179, 4976273, 5050565, 3794915, 4188326, 4367363, 4484604, 4581614, 4645476, 4794789, 4830180, 4976274, 5050573, 3812435, 4201950, 4375667, 4484728, 4583794, 4649445, 4795050, 4830611, 4976275, 5052378, 3822411, 4206043, 4375668, 4484730, 4583795, 4649447, 4795052, 4837569, 4981738, 5056092, 3828557, 4217802, 4375670, 4494938, 4590093, 4666121, 4798012, 4841236, 4981739, 5056098, 3834570, 4223058, 4379438, 4500899, 4599370, 4670683, 4798893, 4842482, 4981741, 5056146, 3856651, 4223059, 4385998, 4500900, 4601759, 4670686, 4798894, 4849535, 4981743, 5056156, 3860662, 4226233, 4386193, 4500901, 4604044, 4670692, 4798895, 4849538, 4983562, 5056157, 3900656, 4234978, 4386196, 4524162, 4606184, 4670695, 4798896, 4854912, 4985073, 5056158, 3947356, 4246621, 4386199, 4528392, 4607129, 4684581, 4798897, 4858801, 4985074, 5056159, 3980664, 4247945, 4386213, 4528394, 4608446, 4689653, 4798898, 4858803, 4985075, 5071158, 3989350, 4252214, 4386219, 4530056, 4614402, 4690469, 4798899, 4858807, 4999738, 5071162, 4004245, 4254255, 4386220, 4530068, 4615032, 4733158, 4803865, 4865777, 5018016, 5073737, 4014734, 4254258, 4390069, 4530069, 4615533, 4733159, 4804015, 4866488, 5018018, 5073738, 4018502, 4262594, 4390076, 4533342, 4615535, 4733161, 4807052, 4866489, 5018019, 5073739, 4057460, 4275962, 4405109, 4534882, 4616911, 4733162, 4813125, 4866513, 5018022, 5073740, 4058912, 4277371, 4406133, 4534883, 4616912, 4733163, 4813133, 4873157, 5018023, 5077981, 4074970, 4282261, 4406134, 4539283, 4618308, 4737222, 4813140, 4873158, 5018498, 5077982, 4081932, 4287761, 4427706, 4539287, 4619851, 4745906, 4817687, 4875001, 5021780, 5077984, 4084034, 4294841, 4435823, 4539290, 4619854, 4745907, 4817689, 4883359, 5038794, 5081366, 4095939, 4302829, 4452359, 4539291, 4619856, 4745908, 4817690, 4896357, 5042549, 5087199, 4097365, 4325230, 4459673, 4553565, 4619863, 4764244, 4817693, 4945462, 5043510, 4097366, 4325232, 4464301, 4553566, 4621608, 4767000, 4821704, 4954754, 5043511.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 5 of 26

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2178-2026

Recall number: Z-2178-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 6 of 26

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2179-2026

Recall number: Z-2179-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003876, Lot Numbers: xxxxx

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 7 of 26

BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2180-2026

Recall number: Z-2180-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003890, Lot Numbers: 4064760, 4336810, 4381356, 4381359, 4401919.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 8 of 26

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2181-2026

Recall number: Z-2181-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 217 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003838, Lot Numbers: 4225215, 4653836, 4793147, 4852429, 4986000, 5023873, 5043553, 4280561, 4672798, 4799184, 4852603, 4986001, 5023874, 5043556, 4287896, 4677462, 4799186, 4854910, 4986002, 5023875, 5043560, 4296580, 4677463, 4799187, 4856657, 4997834, 5023876, 5053722, 4309622, 4693434, 4799188, 4860078, 5003556, 5027296, 5059498, 4309623, 4693435, 4799191, 4860082, 5003557, 5027297, 5059499, 4309846, 4693436, 4799309, 4861298, 5003558, 5027301, 5064680, 4374217, 4693437, 4800061, 4861536, 5003569, 5027406, 5064916, 4396650, 4728693, 4800062, 4939136, 5004167, 5027407, 5071434, 4458557, 4728695, 4800113, 4953662, 5004181, 5027571, 5072250, 4479919, 4733707, 4801993, 4953663, 5007874, 5028963, 5073207, 4497169, 4755043, 4801994, 4963413, 5009259, 5030330, 5073552, 4507933, 4755045, 4807495, 4963414, 5013933, 5031863, 5083312, 4510607, 4755046, 4808706, 4963418, 5013934, 5032745, 5083313, 4551972, 4755047, 4808707, 4966281, 5013949, 5038102, 5084295, 4566389, 4762910, 4809527, 4968920, 5013956, 5038314, 5085197, 4585687, 4773741, 4811620, 4968921, 5016583, 5038317, 4600586, 4777739, 4811622, 4974743, 5016616, 5038318, 4613364, 4786928, 4811625, 4976214, 5018038, 5038321, 4613429, 4786931, 4829506, 4976215, 5018718, 5038782, 4614815, 4793146, 4829507, 4985998, 5020889, 5043552.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 9 of 26

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2182-2026

Recall number: Z-2182-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 44 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825003739, Lot Numbers 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, 5056828.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 10 of 26

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2183-2026

Recall number: Z-2183-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 154 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825011529, Lot Numbers: 3881385, 4808385, 4854113, 4961672, 4974217, 4988584, 4993237, 5016458, 5021634, 5048549, 3921444, 4822971, 4945780, 4961673, 4979107, 4988587, 4994122, 5016460, 5021635, 5050589, 3998693, 4822986, 4945781, 4961674, 4981313, 4988751, 4994128, 5016461, 5021636, 5053395, 4029481, 4822987, 4953683, 4970070, 4982419, 4988752, 4994180, 5016462, 5021637, 5053396, 4369183, 4824246, 4954241, 4970071, 4982421, 4988753, 4998213, 5016463, 5021639, 5060170, 4369245, 4824248, 4961385, 4970361, 4983569, 4988754, 4998214, 5016464, 5021640, 5060171, 4732484, 4824249, 4961665, 4970362, 4986061, 4988755, 5005259, 5016466, 5021641, 5060172, 4751084, 4828822, 4961666, 4970363, 4986062, 4988756, 5005263, 5017692, 5025098, 5060173, 4796276, 4837793, 4961667, 4970364, 4986063, 4990589, 5005264, 5017935, 5025100, 5060174, 4798223, 4846389, 4961668, 4970365, 4986064, 4990590, 5011152, 5018675, 5025101, 5086587, 4801020, 4853335, 4961669, 4970366, 4986065, 4990591, 5014700, 5018677, 5036101, 5086588, 4801021, 4853336, 4961670, 4970367, 4986067, 4990592, 5014702, 5020792, 5042591, 5086590, 4808376, 4854112, 4961671, 4970368, 4986068, 4992498, 5016457, 5021633, 5045829, 5086592.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 11 of 26

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2184-2026

Recall number: Z-2184-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 449 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 07613327357301, Lot Numbers: 2934107, 3695884, 3813841, 3963557, 4293648, 4660245, 4816422, 4937844, 4984006, 5024442, 2964378, 3695885, 3813842, 3963558, 4294641, 4665924, 4816423, 4937846, 4984751, 5024443, 3369649, 3695886, 3813843, 3963559, 4320451, 4665926, 4820652, 4937850, 4985810, 5025866, 3414030, 3695889, 3813844, 3963561, 4320454, 4677505, 4824140, 4937853, 4985813, 5025908, 3487957, 3695898, 3814084, 3963565, 4320584, 4683574, 4824141, 4937876, 4985814, 5025909, 3487959, 3695899, 3814089, 3963923, 4320585, 4690460, 4824142, 4937886, 4985819, 5025913, 3516565, 3695905, 3814090, 3965856, 4352366, 4690461, 4824143, 4937914, 4985820, 5030283, 3516579, 3695909, 3814151, 3971195, 4365471, 4722597, 4824144, 4937921, 4985977, 5030284, 3533495, 3695911, 3814152, 3971196, 4365472, 4722598, 4825584, 4937937, 4985978, 5030285, 3536146, 3695912, 3814379, 3971197, 4371818, 4734903, 4825590, 4938070, 4985980, 5030306, 3563129, 3713425, 3814402, 3971199, 4380641, 4742839, 4828929, 4938075, 4986540, 5030308, 3623660, 3720912, 3814403, 3971200, 4384663, 4770976, 4829405, 4940572, 4990713, 5030309, 3635399, 3720913, 3814404, 3971363, 4384664, 4770977, 4829407, 4940573, 4990727, 5034157, 3639136, 3720914, 3814405, 3991716, 4384665, 4774463, 4829408, 4940574, 4992829, 5034251, 3642928, 3720915, 3814406, 4000629, 4384666, 4774464, 4829409, 4940575, 4998446, 5036560, 3657002, 3720916, 3814407, 4018409, 4384667, 4776002, 4830745, 4952872, 4998448, 5036561, 3657003, 3720919, 3814408, 4020134, 4384668, 4776023, 4830748, 4953149, 4998547, 5040068, 3658634, 3733771, 3814409, 4068043, 4390632, 4799861, 4833289, 4953150, 4998548, 5041755, 3658673, 3741542, 3814410, 4111059, 4400780, 4799862, 4840236, 4953151, 5002404, 5041756, 3659104, 3743987, 3824661, 4115291, 4406069, 4799863, 4841977, 4953153, 5002405, 5041760, 3665462, 3748109, 3824662, 4142838, 4423866, 4800152, 4841978, 4953154, 5002602, 5043056, 3665463, 3766803, 3831087, 4142840, 4423870, 4800155, 4842198, 4953155, 5002603, 5043824, 3665464, 3766807, 3841170, 4142841, 4428699, 4800353, 4842783, 4953156, 5002604, 5043825, 3665465, 3766808, 3843536, 4144673, 4428700, 4801216, 4846033, 4953157, 5002605, 5052577, 3665466, 3770489, 3845330, 4144997, 4438106, 4806963, 4852908, 4953162, 5008310, 5059783, 3670655, 3774007, 3851621, 4181100, 4450156, 4806964, 4854158, 4953183, 5008392, 5059784, 3670656, 3778766, 3851622, 4181101, 4495768, 4806965, 4855585, 4953184, 5008394, 5059785, 3670659, 3778767, 3851623, 4181102, 4498972, 4806966, 4855586, 4960862, 5008412, 5059786, 3670662, 3778769, 3851624, 4199249, 4500710, 4808371, 4855669, 4973101, 5008704, 5059787, 3670665, 3788271, 3851625, 4200117, 4512636, 4811617, 4859421, 4973653, 5008705, 5059788, 3670666, 3792023, 3851626, 4218160, 4519621, 4813305, 4859422, 4978434, 5008750, 5059789, 3684410, 3805982, 3888520, 4225232, 4548019, 4813306, 4865886, 4978435, 5008751, 5067006, 3684411, 3809170, 3888521, 4232774, 4593743, 4813307, 4868858, 4979809, 5017528, 5078231, 3684412, 3809184, 3888524, 4265339, 4617777, 4813310, 4871606, 4979810, 5017529, 5078232, 3691269, 3809306, 3895233, 4265852, 4623978, 4813611, 4871607, 4980427, 5017533, 5081439, 3693634, 3809307, 3944996, 4281497, 4636786, 4813612, 4871608, 4980429, 5017536, 5081440, 3695835, 3811477, 3944997, 4281516, 4637499, 4814211, 4871609, 4980430, 5017539, 5081441, 3695836, 3811480, 3944998, 4281899, 4643511, 4814213, 4871610, 4980836, 5017541, 5083240, 3695850, 3813705, 3953668, 4282025, 4651653, 4814221, 4872209, 4980837, 5021604, 5083242, 3695852, 3813706, 3960483, 4282026, 4653186, 4814228, 4937761, 4980838, 5021606, 5085978, 3695865, 3813707, 3963551, 4282027, 4655459, 4814231, 4937764, 4980870, 5021607, 3695866, 3813708, 3963553, 4282248, 4656625, 4816416, 4937771, 4982864, 5022826, 3695873, 3813709, 3963555, 4282965, 4659207, 4816418, 4937832, 4984004, 5024439, 3695876, 3813839, 3963556, 4292165, 4659209, 4816419, 4937843, 4984005, 5024440.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 12 of 26

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

Z-2185-2026

Recall number: Z-2185-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 816 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

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 pattern

US Nationwide and the countries of Israel and Canada.

device · product 13 of 26

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2186-2026

Recall number: Z-2186-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 319 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825006815, Lot Numbers: 2696145, 3794476, 4262195, 4633829, 4786916, 4849947, 5002352, 2965551, 3812493, 4265992, 4637189, 4792723, 4850691, 5002356, 3152561, 3814730, 4299204, 4637394, 4792893, 4851631, 5002359, 3172403, 3816485, 4337701, 4638269, 4793417, 4851632, 5002471, 3214127, 3851379, 4337958, 4639992, 4793418, 4851633, 5002472, 3229881, 3851380, 4345121, 4640104, 4794109, 4851635, 5008611, 3231417, 3851381, 4347049, 4640298, 4794112, 4862174, 5011458, 3312354, 3856993, 4352168, 4640299, 4794113, 4862621, 5017279, 3391553, 3859715, 4385951, 4644671, 4795044, 4865853, 5017489, 3419988, 3872508, 4395928, 4644672, 4795045, 4867603, 5027374, 3529291, 3895749, 4414258, 4645668, 4797291, 4867987, 5030307, 3535239, 3895751, 4419159, 4645812, 4797920, 4971117, 5031793, 3562006, 3895752, 4423479, 4647311, 4797924, 4971944, 5031878, 3582655, 3901375, 4425060, 4653274, 4797926, 4971947, 5032321, 3603300, 3918234, 4431614, 4664276, 4797930, 4971948, 5032386, 3636415, 3920888, 4437406, 4670462, 4799499, 4974025, 5034496, 3651834, 3937237, 4441090, 4670679, 4801581, 4979034, 5034497, 3655196, 3960672, 4458892, 4670680, 4807674, 4980507, 5034498, 3656249, 3970969, 4462985, 4672993, 4808182, 4980530, 5038587, 3658257, 3991875, 4473952, 4672995, 4808183, 4982050, 5038588, 3665444, 4012832, 4479589, 4672996, 4815394, 4984123, 5043499, 3677212, 4012885, 4481147, 4732567, 4815398, 4984126, 5043827, 3694515, 4071638, 4483708, 4732568, 4815399, 4984748, 5044555, 3709365, 4075854, 4486102, 4735809, 4816696, 4986997, 5044556, 3709396, 4088027, 4486103, 4735812, 4818303, 4986998, 5044557, 3710574, 4090987, 4497350, 4735814, 4818304, 4987268, 5044558, 3727131, 4095290, 4502986, 4735987, 4818306, 4987269, 5057014, 3728355, 4095510, 4502987, 4735988, 4818307, 4987270, 5080098, 3729486, 4097587, 4503631, 4735990, 4819692, 4992590, 5081266, 3747071, 4106743, 4523798, 4738428, 4819695, 4993071, 5081365, 3761145, 4108814, 4523801, 4740253, 4822574, 4993684, 5082367, 3763791, 4115879, 4533536, 4740739, 4826934, 4993689, 5082368, 3763855, 4119335, 4540396, 4741159, 4826935, 4993880, 5082369, 3763856, 4123513, 4549484, 4741160, 4826937, 4993881, 5082370, 3764216, 4149187, 4579089, 4744238, 4826938, 4993882, 5085317, 3770102, 4152148, 4597761, 4744239, 4828151, 4993883, 5085403, 3773860, 4175762, 4608379, 4745443, 4830359, 4993884, 5085404, 3774100, 4177955, 4608381, 4745445, 4833592, 4993885, 5085405, 3787685, 4178577, 4608382, 4749733, 4833593, 4998125, 5085406, 3790359, 4178582, 4610179, 4764854, 4834330, 4998610, 3794458, 4185882, 4613525, 4766335, 4834331, 4998611, 3794460, 4189493, 4615091, 4785653, 4834332, 4998612, 3794462, 4213206, 4624363, 4786265, 4840666, 4999415, 3794467, 4233873, 4630474, 4786266, 4845709, 5002341, 3794473, 4236800, 4631218, 4786915, 4849946, 5002349.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 14 of 26

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2187-2026

Recall number: Z-2187-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825006877, Lot Numbers: 3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, 3683858, 3891551, 3991434, 4052721, 4053586, 4111212, 4496898, 3694871, 3932470, 3991439, 4052723, 4103479, 4111213, 4549309, 3762375, 3942462, 3991442, 4052726, 4103480, 4111214, 4549312, 3764605, 3964790, 3991444, 4052727, 4103481, 4111216, 4570926, 3764606, 3971860, 3991445, 4052735, 4103482, 4111218, 4570936, 3767575, 3973797, 4042769, 4052747, 4103483, 4111219, 4749790, 3767954, 3981001, 4042773, 4053579, 4103491, 4496884, 4753244, 3769052, 3981005, 4042776, 4053580, 4103492, 4496886, 4954168, 3808357, 3981320, 4042777, 4053582, 4103493, 4496892.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 15 of 26

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2188-2026

Recall number: Z-2188-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 16 of 26

Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2189-2026

Recall number: Z-2189-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825006969, Lot Numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, 4720693.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 17 of 26

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2190-2026

Recall number: Z-2190-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 18 of 26

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2191-2026

Recall number: Z-2191-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 1352 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

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 pattern

US Nationwide and the countries of Israel and Canada.

device · product 19 of 26

Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2192-2026

Recall number: Z-2192-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 107 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007270, Lot Numbers: 4026564, 4229299, 4801695, 4953879, 4987354, 5020148, 5075816, 4062382, 4229325, 4820358, 4953880, 4993906, 5034504, 5075889, 4126798, 4274291, 4821138, 4953881, 4993907, 5034505, 5075890, 4133063, 4294908, 4835292, 4953882, 4993909, 5044394, 5075900, 4159795, 4393599, 4841302, 4972396, 4993911, 5044402, 5075908, 4185728, 4487172, 4842791, 4972397, 4998472, 5047707, 4186431, 4550977, 4857135, 4972398, 4998473, 5053484, 4202027, 4574015, 4866297, 4972399, 4998474, 5058443, 4229211, 4584299, 4872587, 4972415, 5004432, 5063958, 4229292, 4594942, 4873162, 4987352, 5014723, 5066753, 4229294, 4737174, 4881443, 4987353, 5019469, 5066980.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 20 of 26

Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2193-2026

Recall number: Z-2193-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007287, Lot Numbers: 3459566, 3623281, 4191726.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 21 of 26

Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2194-2026

Recall number: Z-2194-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007294, Lot Numbers: 3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, 5005455, 5056648.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 22 of 26

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2195-2026

Recall number: Z-2195-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 206 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007300, Lot Numbers: 1772607, 3994138, 4539200, 4808444, 4985924, 5010522, 5042942, 2482952, 4046485, 4539206, 4808677, 4986242, 5010524, 5042944, 2521570, 4164020, 4540476, 4812775, 4986243, 5017909, 5042945, 2521636, 4166570, 4544644, 4817888, 4986244, 5018848, 5043881, 2521660, 4182322, 4549452, 4824089, 4986245, 5020135, 5043883, 2577590, 4183176, 4549458, 4824092, 4986256, 5020136, 5052391, 2711877, 4206584, 4549460, 4824093, 4986399, 5020139, 5056580, 2769403, 4216286, 4551863, 4825561, 4993904, 5020147, 5060152, 2769695, 4247577, 4567736, 4830114, 4993905, 5020149, 5060153, 2787951, 4260013, 4569285, 4833151, 4993910, 5020453, 5060154, 2919616, 4274184, 4569297, 4850593, 4993912, 5024412, 5060155, 2919619, 4275872, 4569532, 4854631, 4993914, 5024413, 5060156, 2919623, 4287229, 4569539, 4854632, 4993915, 5025667, 5060157, 2986771, 4295030, 4577350, 4861162, 4993916, 5029412, 5060158, 3186438, 4390731, 4579539, 4861163, 4993920, 5032327, 5060159, 3269091, 4414236, 4665004, 4861164, 4997912, 5032328, 5060160, 3364168, 4414244, 4671456, 4868220, 4999701, 5032329, 5080121, 3371014, 4461334, 4675658, 4890809, 4999901, 5032330, 5080812, 3371015, 4477262, 4677973, 4950295, 5001378, 5032331, 5081406, 3371464, 4487544, 4734148, 4972469, 5001380, 5033613, 5081407, 3372123, 4487545, 4735713, 4974049, 5003013, 5035986, 5085275, 3398046, 4495634, 4739300, 4974050, 5003014, 5038644, 5085394, 3411209, 4508984, 4748755, 4976259, 5003015, 5038647, 5085395, 3413279, 4539190, 4756237, 4976293, 5003016, 5041264, 5085396, 3469626, 4539191, 4771668, 4985775, 5003017, 5042936, 5085889, 3499568, 4539192, 4792718, 4985776, 5003018, 5042937, 3784873, 4539196, 4804384, 4985921, 5003019, 5042940, 3896863, 4539199, 4808394, 4985922, 5008867, 5042941.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 23 of 26

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2196-2026

Recall number: Z-2196-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007331. Lot Numbers: 3557411, 3702628, 4498116.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 24 of 26

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2197-2026

Recall number: Z-2197-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 458 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007355, Lot Numbers: 4248065, 4625922, 4792899, 4880229, 4947722, 4982083, 5004927, 5022043, 5031874, 5063926, 4253253, 4642049, 4798611, 4880230, 4950352, 4982089, 5004930, 5022044, 5032223, 5063929, 4253255, 4643022, 4804375, 4880231, 4950943, 4982090, 5008468, 5022045, 5032225, 5063931, 4282439, 4650872, 4804411, 4880233, 4950945, 4982091, 5008470, 5022046, 5032226, 5063932, 4369559, 4651469, 4804956, 4880370, 4950946, 4982093, 5008499, 5022051, 5032227, 5063933, 4386017, 4654912, 4808755, 4880374, 4950947, 4982094, 5008537, 5022052, 5033028, 5068012, 4459470, 4666108, 4811587, 4880582, 4950948, 4982095, 5009357, 5022053, 5033804, 5068846, 4464828, 4670429, 4815453, 4880586, 4950949, 4982097, 5012821, 5022055, 5033805, 5070828, 4486895, 4674208, 4816333, 4880587, 4952904, 4983512, 5012842, 5022056, 5034675, 5070908, 4486907, 4674212, 4818581, 4880588, 4952911, 4987173, 5017443, 5022057, 5035406, 5070909, 4487361, 4674869, 4820929, 4880719, 4953421, 4987174, 5019148, 5022060, 5036552, 5071507, 4487365, 4676135, 4820938, 4880721, 4962172, 4987470, 5020249, 5022062, 5039336, 5071508, 4488481, 4679712, 4820950, 4880722, 4963232, 4987471, 5020250, 5022063, 5039339, 5071509, 4490405, 4686708, 4821064, 4880723, 4963402, 4990374, 5020251, 5022066, 5043250, 5071512, 4495375, 4721283, 4824114, 4881023, 4963403, 4990903, 5020253, 5022067, 5045299, 5072178, 4509673, 4733888, 4824179, 4881051, 4963404, 4990904, 5020258, 5024944, 5050759, 5073644, 4521315, 4733892, 4825854, 4881630, 4967560, 4990911, 5020260, 5025536, 5050796, 5073650, 4521322, 4735180, 4825857, 4883295, 4967561, 4992059, 5020261, 5025704, 5053080, 5073655, 4541213, 4743109, 4826624, 4883342, 4967562, 4992464, 5020262, 5025723, 5054956, 5073656, 4541214, 4746540, 4826633, 4883555, 4967563, 4992467, 5020271, 5026509, 5054958, 5075343, 4541215, 4748739, 4826637, 4883556, 4967564, 4992530, 5020274, 5029335, 5054961, 5076771, 4541217, 4750664, 4826641, 4883557, 4967924, 4992531, 5020276, 5029336, 5054962, 5076775, 4541218, 4752092, 4830154, 4883558, 4968645, 4993543, 5020277, 5029338, 5054963, 5076811, 4541559, 4752135, 4831909, 4883562, 4968922, 4993546, 5020282, 5029339, 5054964, 5076815, 4541712, 4753709, 4848437, 4884368, 4968949, 4993744, 5020284, 5029340, 5054965, 5076817, 4541714, 4756256, 4850164, 4884775, 4969151, 4994177, 5020288, 5029341, 5054967, 5077002, 4545192, 4758701, 4856808, 4884777, 4969161, 4994719, 5021665, 5029342, 5056149, 5082665, 4556354, 4758702, 4856813, 4890996, 4974122, 4994890, 5022029, 5029365, 5056460, 5083385, 4596982, 4762175, 4863997, 4938389, 4974141, 4994891, 5022030, 5029366, 5056461, 5083391, 4600390, 4766874, 4863998, 4938390, 4974446, 4996402, 5022031, 5029367, 5056462, 5083394, 4600391, 4770302, 4863999, 4938391, 4980581, 5000019, 5022032, 5029770, 5056463, 5085411, 4600411, 4770806, 4864006, 4938392, 4981030, 5002189, 5022033, 5029771, 5059995, 5086657, 4600413, 4770963, 4865883, 4939498, 4981031, 5002192, 5022034, 5029773, 5060182, 5087306, 4600416, 4772466, 4869245, 4940696, 4981032, 5002193, 5022035, 5030905, 5060183, 4600419, 4774260, 4875724, 4940950, 4981034, 5002940, 5022037, 5031786, 5061556, 4601678, 4774598, 4880219, 4945464, 4981035, 5004185, 5022038, 5031848, 5062679, 4602555, 4777179, 4880220, 4945474, 4982075, 5004922, 5022039, 5031849, 5063808, 4603539, 4778432, 4880222, 4945903, 4982077, 5004923, 5022040, 5031850, 5063831, 4607203, 4780896, 4880226, 4947019, 4982079, 5004924, 5022041, 5031872, 5063902, 4624545, 4781757, 4880228, 4947020, 4982082, 5004926, 5022042, 5031873, 5063917.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 25 of 26

Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2198-2026

Recall number: Z-2198-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI 00885825007324, Lot Numbers: 4101996, 4175347.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

device · product 26 of 26

Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2199-2026

Recall number: Z-2199-2026
Initiated: April 10, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Sustainability Solutions
Quantity: 87 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incomplete seals on sterile product

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seals on sterile product

Code information

UDI00885825011260, Lot Numbers: 4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, 4470118, 4778468, 4848976, 4966193, 4999115, 5029362, 5063586, 4490754, 4796800, 4855294, 4966194, 5002565, 5029363, 5068369, 4509009, 4815121, 4866012, 4966195, 5002566, 5029364, 5076464, 4527883, 4815122, 4874149, 4969132, 5002873, 5029535, 5085337, 4655115, 4820151, 4883354, 4973129, 5009392, 5029698, 5085818, 4720484, 4826777, 4890964, 4981099, 5014818, 5032181, 4730762, 4845060, 4940777, 4982418, 5017600, 5032182, 4754876, 4846853, 4941142, 4987516, 5018180, 5039989, 4758759, 4847494, 4948941, 4989050, 5018181, 5044865.

Distribution pattern

US Nationwide and the countries of Israel and Canada.

Event summary

Source snapshots represented here

Every recalled product in this event

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