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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055",
  "description": "FDA recall Z-2605-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055 (Devices, Class I). 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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2605-2024/enforcement-record",
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      "name": "FDA recall Z-2605-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055",
      "text": "The FDA logged enforcement record Z-2605-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055 — reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-29. Affected lots/codes: a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers:   4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388;  b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers:  3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123;  c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers:  3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390;  d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers:  4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206;  e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers:  4016047, 4016048, 4213398, 4221327,15021312000276,  4344963, 4348391, 4388093, 4389864;  f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers:  4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392;  g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers:  3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865;  h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers:  3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534;  i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers:  3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124;  j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers:  3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125;  k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers:  3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066. A RECORDED FDA enforcement action (occurred=true).",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2605-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2605-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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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        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2605-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2605-2024/boundary",
      "@type": "schema:Claim",
      "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.",
      "claimType": "interpretation",
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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",
        "adjudicator": null
      },
      "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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Status": "recorded"
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            "Value": "Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.",
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            "Value": "a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers:   4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388;  b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers:  3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123;  c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers:  3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390;  d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers:  4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206;  e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers:  4016047, 4016048, 4213398, 4221327,15021312000276,  4344963, 4348391, 4388093, 4389864;  f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers:  4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392;  g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers:  3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865;  h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers:  3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534;  i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers:  3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124;  j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers:  3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125;  k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers:  3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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}