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  "name": "BARD Dynamic Tip Steerable, Product Number 6DYNTP001;",
  "description": "FDA recall Z-2177-2026 — Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable, Product Number 6DYNTP001; (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-2177-2026: Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable, Product Number 6DYNTP001;",
      "text": "The FDA logged enforcement record Z-2177-2026: Stryker Sustainability Solutions is voluntarily recalling BARD Dynamic Tip Steerable, Product Number 6DYNTP001; — reason: Incomplete seals on sterile product. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-10. Affected lots/codes: 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.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2177-2026 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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      "@type": "schema:Claim",
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      "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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