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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;   b)\t3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030;   c)\t3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035;   d)\t4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040;   e)\t2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025;   f)\t3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030;   g)\t3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035;    h)\t4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040;   i)\t4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045;   j)\t5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050;   k)\t5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055",
  "description": "FDA recall Z-2615-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;   b)\t3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030;   c)\t3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035;   d)\t4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040;   e)\t2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025;   f)\t3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030;   g)\t3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035;    h)\t4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040;   i)\t4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045;   j)\t5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050;   k)\t5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055 (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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    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;   b)\t3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030;   c)\t3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035;   d)\t4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040;   e)\t2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025;   f)\t3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030;   g)\t3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035;    h)\t4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040;   i)\t4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045;   j)\t5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050;   k)\t5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055",
    "manufacturer": {
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      "name": "FDA recall Z-2615-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;   b)\t3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030;   c)\t3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035;   d)\t4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040;   e)\t2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025;   f)\t3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030;   g)\t3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035;    h)\t4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040;   i)\t4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045;   j)\t5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050;   k)\t5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055",
      "text": "The FDA logged enforcement record Z-2615-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025;   b)\t3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030;   c)\t3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035;   d)\t4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040;   e)\t2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025;   f)\t3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030;   g)\t3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035;    h)\t4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040;   i)\t4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045;   j)\t5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050;   k)\t5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055 — 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 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers:   3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802;  b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers:   3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158;  c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers:  3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146;  d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers:  3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803;  e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160;    f) UDI/DI¿15021312000696,  Product Code/List Number/Item Code 67SP030, Lot Numbers:  3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654;  g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers:  3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655;  h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers:  3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079;   i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161;    j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers:  3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656;  k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers:   3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657. A RECORDED FDA enforcement action (occurred=true).",
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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-2615-2024&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-2615-2024&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-2615-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2615-2024 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",
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      "epistemicStatus": {
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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-2615-2024&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-2615-2024&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-2615-2024/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,
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        "supported": 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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            "Value": "Ongoing — the recall is still being carried out.",
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          "position": 5,
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            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
            "Status": "recorded"
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            "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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            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers:   3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802;  b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers:   3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158;  c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers:  3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146;  d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers:  3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803;  e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160;    f) UDI/DI¿15021312000696,  Product Code/List Number/Item Code 67SP030, Lot Numbers:  3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654;  g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers:  3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655;  h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers:  3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079;   i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161;    j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers:  3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656;  k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers:   3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}