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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;   b)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030;   c)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;   d)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040;   e)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045;   f)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050;   g)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055",
  "description": "FDA recall Z-2610-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;   b)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030;   c)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;   d)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040;   e)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045;   f)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050;   g)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055 (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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    "name": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;   b)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030;   c)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;   d)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040;   e)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045;   f)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050;   g)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055",
    "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-2610-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2610-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;   b)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030;   c)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;   d)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040;   e)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045;   f)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050;   g)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055",
      "text": "The FDA logged enforcement record Z-2610-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025;   b)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030;   c)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035;   d)\tTTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040;   e)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045;   f)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050;   g)\tTTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055 — 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 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers:   3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744;  b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers:  3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626;  c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers:  3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129;  d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers:  3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627;  e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers:  3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628;  f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers:  3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132;  g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers:  3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
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        "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-2610-2024&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-2610-2024&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-2610-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2610-2024 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-2610-2024&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-2610-2024&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-2610-2024/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-2610-2024",
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            "Value": "Z-2610-2024",
            "Status": "recorded"
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            "Value": "Devices",
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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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          "@type": "schema:ListItem",
          "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"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers:   3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744;  b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers:  3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626;  c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers:  3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129;  d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers:  3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627;  e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers:  3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628;  f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers:  3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132;  g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers:  3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
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    }
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}