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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2612-2024.jsonld",
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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60",
  "description": "FDA recall Z-2612-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Smiths Medical ASD Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2612-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2612-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60",
      "text": "The FDA logged enforcement record Z-2612-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60 — 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 10351688518545, Product Code/List Number/Item Code 67PFPS40, Lot Numbers:  3853396, 3853397, 3853398, 3868287, 3877646, 3887734, 3894892, 3901306, 3917987, 3920965, 3926974, 3939653, 3942530, 3955815, 3959315, 3959316, 3959317, 3988071, 3988072, 4011361, 4023779, 4033704, 4035702, 4041960, 4051672, 4053712, 4066299, 4092625, 4100899, 4107607, 4113098, 4119102, 4125822, 4130993, 4136123, 4145709, 4156646, 4159981, 4171577, 4180482, 4196258, 4216309, 4218696, 4237356, 4260055, 4276448, 4286793, 4292157, 4331570, 4334903, 4344976, 4348417, 4358474, 4358475, 4362844, 4380995, 4383602, 4388113, 4388114, 4389872, 4395749, 4399133;  b) UDI/DI10351688518552, Product Code/List Number/Item Code 67PFPS45, Lot Numbers:  3853399, 3864259, 3871049, 3880700, 3887735, 3894893, 3904657, 3917998, 3920966, 3931144, 3936564, 3942550, 3952415, 3952416, 3965904, 3981981, 3997802, 3997803, 4011362, 4018501, 4026672, 4033705, 4035703, 4041959, 4048016, 4053711, 4060204, 4077079, 4089300, 4096828, 4107614, 4116110, 4136124, 4145679, 4153608, 4161964, 4173724, 4176222, 4218697, 4237357, 4240127, 4276449, 4286794, 4289467, 4331571, 4333981, 4334904, 4348418, 4358480, 4358481, 4383604, 4388115, 4388116, 4395751, 4399134, 4400632;   c) UDI/DI 10351688518569, Product Code/List Number/Item Code 67PFPS50, Lot Numbers:  3853400, 3868255, 3868256, 3871037, 3877662, 3887725, 3891536, 3894881, 3907982, 3918012, 3920957, 3920958, 3920959, 3930023, 3930025, 3946300, 3955761, 3965917, 3981984, 3981985, 4015529, 4023780, 4033706, 4035704, 4048031, 4051664, 4063168, 4083922, 4086013, 4092643, 4097826, 4128041, 4138975, 4145689, 4151042, 4156625, 4161977, 4173725, 4213404, 4216310, 4254218, 4260056, 4292158, 4322658, 4329834, 4334223, 4358477, 4358478, 4393392, 4395752, 4399135;  d) UDI/DI 10351688518576, Product Code/List Number/Item Code 67PFPS55, Lot Numbers:  3853401, 3868254, 3874321, 3880684, 3894880, 3907981, 3920961, 3930021, 3930022, 3942516, 3942517, 3946299, 3955759, 3955760, 3962586, 3965916, 3987943, 4005589, 4011363, 4021414, 4023781, 4043936, 4063169, 4086012, 4092645, 4097827, 4113102, 4119092, 4130982, 4138982, 4142445, 4145683, 4153625, 4156624, 4159961, 4173726, 4179341, 4185408, 4196259, 4213405, 4254219, 4276450, 4279322, 4327892, 4329835, 4334224, 4344977, 4369560, 4388117, 4389873, 4395753, 4399136;   e) UDI/DI 10351688518583, Product Code/List Number/Item Code 67PFPS60, Lot Numbers: 3802149, 3802150, 3832051, 3853402, 3868269, 3871040, 3874313, 3877671, 3880685, 3887730, 3894912, 3904651, 3907974, 3907975, 3914572, 3917992, 3917993, 3942540, 3942541, 3959322, 3981987, 3981989, 3987944, 4008200, 4018502, 4021419, 4023782, 4029495, 4033707, 4035705, 4038944, 4048013, 4053728, 4071977, 4077106, 4083927, 4091407, 4095926, 4100901, 4110434, 4119104, 4142440, 4163846, 4176249, 4185409, 4197605, 4233739, 4237358, 4237398, 4240128, 4247285, 4254220, 4319265, 4334907, 4352771, 4374409, 4380996, 4380997, 4380998, 4383605, 4389874, 4399137, 4400634, 4319265-ENG. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2612-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2612-2024&lang=eng"
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2612-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2612-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2612-2024&lang=eng",
        "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-2612-2024&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-2612-2024/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",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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      "name": "FDA recall details — Z-2612-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2612-2024",
            "Status": "recorded"
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          "position": 2,
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "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.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 10351688518545, Product Code/List Number/Item Code 67PFPS40, Lot Numbers:  3853396, 3853397, 3853398, 3868287, 3877646, 3887734, 3894892, 3901306, 3917987, 3920965, 3926974, 3939653, 3942530, 3955815, 3959315, 3959316, 3959317, 3988071, 3988072, 4011361, 4023779, 4033704, 4035702, 4041960, 4051672, 4053712, 4066299, 4092625, 4100899, 4107607, 4113098, 4119102, 4125822, 4130993, 4136123, 4145709, 4156646, 4159981, 4171577, 4180482, 4196258, 4216309, 4218696, 4237356, 4260055, 4276448, 4286793, 4292157, 4331570, 4334903, 4344976, 4348417, 4358474, 4358475, 4362844, 4380995, 4383602, 4388113, 4388114, 4389872, 4395749, 4399133;  b) UDI/DI10351688518552, Product Code/List Number/Item Code 67PFPS45, Lot Numbers:  3853399, 3864259, 3871049, 3880700, 3887735, 3894893, 3904657, 3917998, 3920966, 3931144, 3936564, 3942550, 3952415, 3952416, 3965904, 3981981, 3997802, 3997803, 4011362, 4018501, 4026672, 4033705, 4035703, 4041959, 4048016, 4053711, 4060204, 4077079, 4089300, 4096828, 4107614, 4116110, 4136124, 4145679, 4153608, 4161964, 4173724, 4176222, 4218697, 4237357, 4240127, 4276449, 4286794, 4289467, 4331571, 4333981, 4334904, 4348418, 4358480, 4358481, 4383604, 4388115, 4388116, 4395751, 4399134, 4400632;   c) UDI/DI 10351688518569, Product Code/List Number/Item Code 67PFPS50, Lot Numbers:  3853400, 3868255, 3868256, 3871037, 3877662, 3887725, 3891536, 3894881, 3907982, 3918012, 3920957, 3920958, 3920959, 3930023, 3930025, 3946300, 3955761, 3965917, 3981984, 3981985, 4015529, 4023780, 4033706, 4035704, 4048031, 4051664, 4063168, 4083922, 4086013, 4092643, 4097826, 4128041, 4138975, 4145689, 4151042, 4156625, 4161977, 4173725, 4213404, 4216310, 4254218, 4260056, 4292158, 4322658, 4329834, 4334223, 4358477, 4358478, 4393392, 4395752, 4399135;  d) UDI/DI 10351688518576, Product Code/List Number/Item Code 67PFPS55, Lot Numbers:  3853401, 3868254, 3874321, 3880684, 3894880, 3907981, 3920961, 3930021, 3930022, 3942516, 3942517, 3946299, 3955759, 3955760, 3962586, 3965916, 3987943, 4005589, 4011363, 4021414, 4023781, 4043936, 4063169, 4086012, 4092645, 4097827, 4113102, 4119092, 4130982, 4138982, 4142445, 4145683, 4153625, 4156624, 4159961, 4173726, 4179341, 4185408, 4196259, 4213405, 4254219, 4276450, 4279322, 4327892, 4329835, 4334224, 4344977, 4369560, 4388117, 4389873, 4395753, 4399136;   e) UDI/DI 10351688518583, Product Code/List Number/Item Code 67PFPS60, Lot Numbers: 3802149, 3802150, 3832051, 3853402, 3868269, 3871040, 3874313, 3877671, 3880685, 3887730, 3894912, 3904651, 3907974, 3907975, 3914572, 3917992, 3917993, 3942540, 3942541, 3959322, 3981987, 3981989, 3987944, 4008200, 4018502, 4021419, 4023782, 4029495, 4033707, 4035705, 4038944, 4048013, 4053728, 4071977, 4077106, 4083927, 4091407, 4095926, 4100901, 4110434, 4119104, 4142440, 4163846, 4176249, 4185409, 4197605, 4233739, 4237358, 4237398, 4240128, 4247285, 4254220, 4319265, 4334907, 4352771, 4374409, 4380996, 4380997, 4380998, 4383605, 4389874, 4399137, 4400634, 4319265-ENG",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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}