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  "name": "Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER",
  "description": "FDA recall Z-2197-2026 — Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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      "name": "FDA recall Z-2197-2026: Stryker Sustainability Solutions is recalling Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER",
      "text": "The FDA logged enforcement record Z-2197-2026: Stryker Sustainability Solutions is voluntarily recalling Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER — reason: Incomplete seals on sterile product. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-10. Affected lots/codes: 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.. A RECORDED FDA enforcement action (occurred=true).",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-2197-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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