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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2589-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tAIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;    b)\tAIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170;   c)\tAIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180",
  "description": "FDA recall Z-2589-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tAIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;    b)\tAIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170;   c)\tAIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180 (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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tAIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;    b)\tAIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170;   c)\tAIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180",
    "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-2589-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2589-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tAIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;    b)\tAIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170;   c)\tAIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180",
      "text": "The FDA logged enforcement record Z-2589-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tAIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160;    b)\tAIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170;   c)\tAIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180 — 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 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers:  3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458;  b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers:  3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 3839572, 3845070, 3849724, 3852697, 3870312, 3870313, 3870314, 3870315, 3870316, 3870317, 3870318, 3870319, 3897727, 3901072, 3901073, 3904426, 3939373, 3942402, 3952277, 3962454, 3973201, 3980528, 3988247, 3991258, 3991639, 4005726, 4008258, 4008259, 4008260, 4018554, 4021437, 4026720, 4033787, 4067208, 4070878, 4096871, 4097851, 4101024, 4107646, 4115311, 4117748, 4122529, 4128080, 4131075, 4134121, 4136191, 4139082, 4142533, 4145790, 4148043, 4151104, 4153681, 4171674, 4171675, 4173694, 4176260, 4178829, 4185497, 4192841, 4197661, 4197662, 4257859, 4263229, 4283185, 4309561, 4331671, 4363783, 4366576, 4376167, 4384907, 4393384;  c) UDI/DI 15021312006421, Product Code/List Number/Item Code 750180, lot Numbers:  3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3797125, 3800602, 3801535, 3801536, 3801537, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3839573, 3839574, 3839575, 3870213, 3870214, 3870215, 3870216, 3870217, 3870218, 3870219, 3870220, 3870221, 3894701, 3894702, 3894703, 3894704, 3894705, 3894706, 3901032, 3901033, 3904488, 3904489, 3952216, 3952217, 3959218, 3962463, 3984950, 3988248, 4002283, 4002284, 4002285, 4005749, 4005750, 4015644, 4015645, 4021438, 4021439, 4033788, 4046816, 4054563, 4077143, 4080839, 4083962, 4092689, 4095943, 4096887, 4097852, 4105325, 4107661, 4110491, 4119152, 4125917, 4128114, 4131094, 4136209, 4139048, 4163867, 4168109, 4173695, 4178830, 4180539, 4185498, 4192842, 4192843, 4201737, 4205254, 4216366, 4229366, 4233997, 4242056, 4255460, 4291924, 4293044, 4331672, 4335537, 4346834, 4371674, 4371675, 4390913, 4391733, 4393385, 4393386, 4401163. 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-2589-2024&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-2589-2024&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-2589-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2589-2024 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-2589-2024&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-2589-2024&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-2589-2024/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
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      "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-2589-2024",
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            "Field": "Recall number",
            "Value": "Z-2589-2024",
            "Status": "recorded"
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          "position": 2,
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
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            "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 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers:  3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458;  b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers:  3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 3839572, 3845070, 3849724, 3852697, 3870312, 3870313, 3870314, 3870315, 3870316, 3870317, 3870318, 3870319, 3897727, 3901072, 3901073, 3904426, 3939373, 3942402, 3952277, 3962454, 3973201, 3980528, 3988247, 3991258, 3991639, 4005726, 4008258, 4008259, 4008260, 4018554, 4021437, 4026720, 4033787, 4067208, 4070878, 4096871, 4097851, 4101024, 4107646, 4115311, 4117748, 4122529, 4128080, 4131075, 4134121, 4136191, 4139082, 4142533, 4145790, 4148043, 4151104, 4153681, 4171674, 4171675, 4173694, 4176260, 4178829, 4185497, 4192841, 4197661, 4197662, 4257859, 4263229, 4283185, 4309561, 4331671, 4363783, 4366576, 4376167, 4384907, 4393384;  c) UDI/DI 15021312006421, Product Code/List Number/Item Code 750180, lot Numbers:  3710823, 3778495, 3778496, 3782548, 3789963, 3789964, 3789965, 3789966, 3797125, 3800602, 3801535, 3801536, 3801537, 3827976, 3827977, 3827978, 3827979, 3827980, 3827981, 3827982, 3839573, 3839574, 3839575, 3870213, 3870214, 3870215, 3870216, 3870217, 3870218, 3870219, 3870220, 3870221, 3894701, 3894702, 3894703, 3894704, 3894705, 3894706, 3901032, 3901033, 3904488, 3904489, 3952216, 3952217, 3959218, 3962463, 3984950, 3988248, 4002283, 4002284, 4002285, 4005749, 4005750, 4015644, 4015645, 4021438, 4021439, 4033788, 4046816, 4054563, 4077143, 4080839, 4083962, 4092689, 4095943, 4096887, 4097852, 4105325, 4107661, 4110491, 4119152, 4125917, 4128114, 4131094, 4136209, 4139048, 4163867, 4168109, 4173695, 4178830, 4180539, 4185498, 4192842, 4192843, 4201737, 4205254, 4216366, 4229366, 4233997, 4242056, 4255460, 4291924, 4293044, 4331672, 4335537, 4346834, 4371674, 4371675, 4390913, 4391733, 4393385, 4393386, 4401163",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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}