--- title: "Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY... — FDA record Z-2197-2026 | Is It on Recall" description: "Incomplete seals on sterile product" url: https://isitonrecall.com/recall/fda-device-z-2197-2026-daig-livewire-steerable-product-number-401932-reprocessed-electrophysiology-catheter/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER — FDA record Z-2197-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Apr 10, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER - **Reason**: Incomplete seals on sterile product - **Classification**: Class II - **Recalling firm**: Stryker Sustainability Solutions - **Quantity**: 458 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2197-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2197-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide and the countries of Israel and Canada. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: May 20, 2026 - **Recall initiation date**: Apr 10, 2026 - **Center classification date**: May 13, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2197-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Stryker Sustainability Solutions records](https://isitonrecall.com/brand/stryker-sustainability-solutions/)