{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2604-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;",
  "description": "FDA recall Z-2604-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055; (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",
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    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-2604-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Smiths Medical ASD Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2604-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2604-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;",
      "text": "The FDA logged enforcement record Z-2604-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055; — 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 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes:   3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619;  b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes:  3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089;  c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes:  3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735;  d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes:  3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591;  e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes:  3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620;  f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes:   3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090,  g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P055, Lot Codes:  3840082, 3871043, 3871044, 3901291, 3926980, 3942462, 3942463, 3952341, 3959335, 4011352, 4035681, 4056231, 4077094, 4083913, 4100882, 4107599, 4119123, 4134024, 4138988, 4153615, 4159942, 4168155, 4173721, 4180495, 4195801, 4213395, 4218688, 4267837, 4334869, 4344349, 4351229, 4351230, 4353075, 4389862, 4389863, 4400621. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-2604-2024&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-2604-2024&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-2604-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2604-2024 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
      },
      "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-2604-2024&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-2604-2024&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-2604-2024/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-2604-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2604-2024",
            "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes:   3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619;  b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes:  3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089;  c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes:  3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735;  d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes:  3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591;  e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes:  3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620;  f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes:   3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090,  g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P055, Lot Codes:  3840082, 3871043, 3871044, 3901291, 3926980, 3942462, 3942463, 3952341, 3959335, 4011352, 4035681, 4056231, 4077094, 4083913, 4100882, 4107599, 4119123, 4134024, 4138988, 4153615, 4159942, 4168155, 4173721, 4180495, 4195801, 4213395, 4218688, 4267837, 4334869, 4344349, 4351229, 4351230, 4353075, 4389862, 4389863, 4400621",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}