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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2596-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;   b)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45;   c)\tPAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50;   d)\tPAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55",
  "description": "FDA recall Z-2596-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;   b)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45;   c)\tPAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50;   d)\tPAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55 (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2596-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;   b)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45;   c)\tPAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50;   d)\tPAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Smiths Medical ASD Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2596-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2596-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;   b)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45;   c)\tPAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50;   d)\tPAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55",
      "text": "The FDA logged enforcement record Z-2596-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40;   b)\tPAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45;   c)\tPAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50;   d)\tPAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55 — 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 15021312005806, Product Code/List Number/Item Code 60PFP40, Lot Numbers:  3868314, 3874308, 3880719, 3887716, 3887717, 3901303, 3907999, 3918005, 3918006, 3942497, 3946273, 3946274, 3955779, 3962577, 3982658, 3997815, 4001202, 4015539, 4026677, 4033721, 4035732, 4038946, 4051654, 4056235, 4071987, 4077111, 4080792, 4086023, 4091403, 4093730, 4097832, 4116083, 4139002, 4153592, 4159948, 4159972, 4168179, 4171543, 4176236, 4180453, 4201373, 4218705, 4221342, 4237380, 4334991, 4345007, 4348460, 4358483, 4383624, 4399170;  b) UDI/DI 15021312005813, Product Code/List Number/Item Code 60PFP45, Lot Numbers:  3802254, 3853446, 3868246, 3874301, 3880687, 3891528, 3894908, 3904654, 3918008, 3936581, 3939674, 3946285, 3949026, 3955771, 3955772, 3982659, 3997816, 4005641, 4018518, 4029507, 4035733, 4049431, 4092628, 4093731, 4105251, 4110447, 4122423, 4136138, 4139017, 4147996, 4156604, 4159996, 4168151, 4171544, 4180471, 4212775, 4237381, 4247292, 4334992, 4345008, 4348461, 4358485, 4379939, 4388163;    c) UDI/DI 15021312005820, Product Code/List Number/Item Code 60PFP50, Lot Numbers:  3853447, 3853448, 3868225, 3901289, 3931140, 3942461, 3952342, 3952343, 3959336, 3982660, 3982661, 3991152, 4005642, 4018517, 4029508, 4035734, 4043937, 4051623, 4060209, 4070852, 4077093, 4086007, 4093732, 4105257, 4110448, 4110449, 4122435, 4138987, 4151048, 4156613, 4171545, 4176220, 4180494, 4218706, 4254243, 4334995, 4348462, 4365775, 4366206;  d) UDI/DI 15021312014754, Product Code/List Number/Item Code 60PFP55, Lot Numbers:  3868227, 3880723, 3894910, 3904680, 3952400, 3959306, 3982662, 4001203, 4005644, 4051658, 4056243, 4063181, 4093733, 4107592, 4122456, 4134029, 4156629, 4163836, 4206815, 4233962, 4334996, 4347203, 4358488, 4388164, 4399172. 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-2596-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-2596-2024&lang=eng"
        }
      },
      "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-2596-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2596-2024 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": {
        "groundingType": "AdjudicativeAct",
        "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-2596-2024&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-2596-2024&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-2596-2024/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-2596-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2596-2024",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "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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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 15021312005806, Product Code/List Number/Item Code 60PFP40, Lot Numbers:  3868314, 3874308, 3880719, 3887716, 3887717, 3901303, 3907999, 3918005, 3918006, 3942497, 3946273, 3946274, 3955779, 3962577, 3982658, 3997815, 4001202, 4015539, 4026677, 4033721, 4035732, 4038946, 4051654, 4056235, 4071987, 4077111, 4080792, 4086023, 4091403, 4093730, 4097832, 4116083, 4139002, 4153592, 4159948, 4159972, 4168179, 4171543, 4176236, 4180453, 4201373, 4218705, 4221342, 4237380, 4334991, 4345007, 4348460, 4358483, 4383624, 4399170;  b) UDI/DI 15021312005813, Product Code/List Number/Item Code 60PFP45, Lot Numbers:  3802254, 3853446, 3868246, 3874301, 3880687, 3891528, 3894908, 3904654, 3918008, 3936581, 3939674, 3946285, 3949026, 3955771, 3955772, 3982659, 3997816, 4005641, 4018518, 4029507, 4035733, 4049431, 4092628, 4093731, 4105251, 4110447, 4122423, 4136138, 4139017, 4147996, 4156604, 4159996, 4168151, 4171544, 4180471, 4212775, 4237381, 4247292, 4334992, 4345008, 4348461, 4358485, 4379939, 4388163;    c) UDI/DI 15021312005820, Product Code/List Number/Item Code 60PFP50, Lot Numbers:  3853447, 3853448, 3868225, 3901289, 3931140, 3942461, 3952342, 3952343, 3959336, 3982660, 3982661, 3991152, 4005642, 4018517, 4029508, 4035734, 4043937, 4051623, 4060209, 4070852, 4077093, 4086007, 4093732, 4105257, 4110448, 4110449, 4122435, 4138987, 4151048, 4156613, 4171545, 4176220, 4180494, 4218706, 4254243, 4334995, 4348462, 4365775, 4366206;  d) UDI/DI 15021312014754, Product Code/List Number/Item Code 60PFP55, Lot Numbers:  3868227, 3880723, 3894910, 3904680, 3952400, 3959306, 3982662, 4001203, 4005644, 4051658, 4056243, 4063181, 4093733, 4107592, 4122456, 4134029, 4156629, 4163836, 4206815, 4233962, 4334996, 4347203, 4358488, 4388164, 4399172",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
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  ]
}