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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1505-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical convenience kits labeled as:    1) NEONATAL INTUBATION TRAY, REF ACC010371C;   2) NEWBORN RESUSCITATION KIT, REF ACC010381A;   3) NEWBORN RESUSCITATION KIT, REF ACC010381B;   4) NEWBORN RESUSCITATION KIT, REF ACC010381C;   5) PEDS GREY-PINK-RED, REF ACC010395;   6) PEDS PURPLE, REF ACC010397;   7) NEONATAL INTUBATION TRAY, REF ACC010541A;   8) NEONATAL INTUBATION TRAY, REF ACC010541B;   9) NEONATAL INTUBATION TRAY, REF ACC010541C;   10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.",
  "description": "FDA recall Z-1505-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical convenience kits labeled as:    1) NEONATAL INTUBATION TRAY, REF ACC010371C;   2) NEWBORN RESUSCITATION KIT, REF ACC010381A;   3) NEWBORN RESUSCITATION KIT, REF ACC010381B;   4) NEWBORN RESUSCITATION KIT, REF ACC010381C;   5) PEDS GREY-PINK-RED, REF ACC010395;   6) PEDS PURPLE, REF ACC010397;   7) NEONATAL INTUBATION TRAY, REF ACC010541A;   8) NEONATAL INTUBATION TRAY, REF ACC010541B;   9) NEONATAL INTUBATION TRAY, REF ACC010541C;   10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252. (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": {
      "@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-1505-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical convenience kits labeled as:    1) NEONATAL INTUBATION TRAY, REF ACC010371C;   2) NEWBORN RESUSCITATION KIT, REF ACC010381A;   3) NEWBORN RESUSCITATION KIT, REF ACC010381B;   4) NEWBORN RESUSCITATION KIT, REF ACC010381C;   5) PEDS GREY-PINK-RED, REF ACC010395;   6) PEDS PURPLE, REF ACC010397;   7) NEONATAL INTUBATION TRAY, REF ACC010541A;   8) NEONATAL INTUBATION TRAY, REF ACC010541B;   9) NEONATAL INTUBATION TRAY, REF ACC010541C;   10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1505-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1505-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical convenience kits labeled as:    1) NEONATAL INTUBATION TRAY, REF ACC010371C;   2) NEWBORN RESUSCITATION KIT, REF ACC010381A;   3) NEWBORN RESUSCITATION KIT, REF ACC010381B;   4) NEWBORN RESUSCITATION KIT, REF ACC010381C;   5) PEDS GREY-PINK-RED, REF ACC010395;   6) PEDS PURPLE, REF ACC010397;   7) NEONATAL INTUBATION TRAY, REF ACC010541A;   8) NEONATAL INTUBATION TRAY, REF ACC010541B;   9) NEONATAL INTUBATION TRAY, REF ACC010541C;   10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.",
      "text": "The FDA logged enforcement record Z-1505-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline medical convenience kits labeled as:    1) NEONATAL INTUBATION TRAY, REF ACC010371C;   2) NEWBORN RESUSCITATION KIT, REF ACC010381A;   3) NEWBORN RESUSCITATION KIT, REF ACC010381B;   4) NEWBORN RESUSCITATION KIT, REF ACC010381C;   5) PEDS GREY-PINK-RED, REF ACC010395;   6) PEDS PURPLE, REF ACC010397;   7) NEONATAL INTUBATION TRAY, REF ACC010541A;   8) NEONATAL INTUBATION TRAY, REF ACC010541B;   9) NEONATAL INTUBATION TRAY, REF ACC010541C;   10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252. — reason: Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-24. Affected lots/codes: 1) REF ACC010371C:  UDI/DI 10193489268188 (ea) 40193489268189 (case), Lot Numbers:   20DDA921, 20EDC042, 20IDC153, 21ADB113, 21CDB435, 21HDB557, 21JDA180, 21LDB244, 22HDB092, 22IDA205, 22JDA908, 22KDA049, 22LDA351, 23EDC611;   2) REF ACC010381A:  UDI/DI 10193489800944 (ea) 40193489800945 (case), Lot Numbers:   20BDB854, 20FDA703;   3) REF ACC010381B:  UDI/DI 10193489457803 (ea) 401934894578049 (case), Lot Numbers:   20LDA314, 20LDA466, 21ADB162, 21BDB508;   4) REF ACC010381C:   UDI/DI 10193489922127 (ea) 40193489922128 (case), Lot Numbers:   21IDA608, 21JDB271, 21KDA979, 21LDA450, 22BDA818, 22FDB822, 22KDB696, 23ADA938, 23CDA005, 23CDB015, 23EDA977, 23FDB762, 23IDB196, 23LDA440, 23LDB579, 24CDA637, 24GDB084, 24IDB423, 24JDB726, 24KDB730;   5) REF ACC010395:   UDI/DI 10193489218152 (ea) 40193489218153 (case), Lot Numbers:  20BDC901;   6) REF ACC010397:  UDI/DI 10193489218169 (ea) 40193489218160 (case), Lot Numbers:   20CDA453, 20CDA459, 20EDB330;   7) REF ACC010541A:   UDI/DI 10195327036980 (ea) 40195327036981 (case), Lot Numbers:  22ADA311;   8) REF ACC010541B:  UDI/DI 10195327153649 (ea) 40195327153640 (case), Lot Numbers:  22EDB187;   9) REF ACC010541C:   UDI/DI 10198459155765 (ea) 40198459155766 (case), Lot Numbers:  24JDC035;   10) REF DYNJAA252:  UDI/DI 10193489297980 (ea) 40193489297981 (case), Lot Numbers:  20EBC867, 20EBD635, 20FBJ920, 22FBF130, 22IBP405. 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-1505-2025&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-1505-2025&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-1505-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1505-2025 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-1505-2025&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-1505-2025&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-1505-2025/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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1505-2025",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1505-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-02-24",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF ACC010371C:  UDI/DI 10193489268188 (ea) 40193489268189 (case), Lot Numbers:   20DDA921, 20EDC042, 20IDC153, 21ADB113, 21CDB435, 21HDB557, 21JDA180, 21LDB244, 22HDB092, 22IDA205, 22JDA908, 22KDA049, 22LDA351, 23EDC611;   2) REF ACC010381A:  UDI/DI 10193489800944 (ea) 40193489800945 (case), Lot Numbers:   20BDB854, 20FDA703;   3) REF ACC010381B:  UDI/DI 10193489457803 (ea) 401934894578049 (case), Lot Numbers:   20LDA314, 20LDA466, 21ADB162, 21BDB508;   4) REF ACC010381C:   UDI/DI 10193489922127 (ea) 40193489922128 (case), Lot Numbers:   21IDA608, 21JDB271, 21KDA979, 21LDA450, 22BDA818, 22FDB822, 22KDB696, 23ADA938, 23CDA005, 23CDB015, 23EDA977, 23FDB762, 23IDB196, 23LDA440, 23LDB579, 24CDA637, 24GDB084, 24IDB423, 24JDB726, 24KDB730;   5) REF ACC010395:   UDI/DI 10193489218152 (ea) 40193489218153 (case), Lot Numbers:  20BDC901;   6) REF ACC010397:  UDI/DI 10193489218169 (ea) 40193489218160 (case), Lot Numbers:   20CDA453, 20CDA459, 20EDB330;   7) REF ACC010541A:   UDI/DI 10195327036980 (ea) 40195327036981 (case), Lot Numbers:  22ADA311;   8) REF ACC010541B:  UDI/DI 10195327153649 (ea) 40195327153640 (case), Lot Numbers:  22EDB187;   9) REF ACC010541C:   UDI/DI 10198459155765 (ea) 40198459155766 (case), Lot Numbers:  24JDC035;   10) REF DYNJAA252:  UDI/DI 10193489297980 (ea) 40193489297981 (case), Lot Numbers:  20EBC867, 20EBD635, 20FBJ920, 22FBF130, 22IBP405",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "California",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}