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    "occurred": "au:occurred",
    "supported": "au:supported",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2703-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure kits labeled as follows:      a) BASIC NASAL, REF DYNJ909932;   b) BRONCH KIT, REF DYKE1007B;   c) ENT, REF DYNJ909935;   d) NASAL SINUS-LF, REF DYNJ902624G;   e) ORAL, REF DYNJ902377I;   f) PACK,BRONCHOSCOPY, REF DYNJ65475B;   g) PACK,HEAD AND NECK, REF DYNJ65487B;   h) PACK,SINUS, REF DYNJ906898;   i) PACK,T & A, REF DYNJ906897B;   j) PACK,T & A ASC, REF DYNJ906914;   k) T AND A, REF DYNJ909941",
  "description": "FDA recall Z-2703-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:      a) BASIC NASAL, REF DYNJ909932;   b) BRONCH KIT, REF DYKE1007B;   c) ENT, REF DYNJ909935;   d) NASAL SINUS-LF, REF DYNJ902624G;   e) ORAL, REF DYNJ902377I;   f) PACK,BRONCHOSCOPY, REF DYNJ65475B;   g) PACK,HEAD AND NECK, REF DYNJ65487B;   h) PACK,SINUS, REF DYNJ906898;   i) PACK,T & A, REF DYNJ906897B;   j) PACK,T & A ASC, REF DYNJ906914;   k) T AND A, REF DYNJ909941 (Devices, Class II). 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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2703-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure kits labeled as follows:      a) BASIC NASAL, REF DYNJ909932;   b) BRONCH KIT, REF DYKE1007B;   c) ENT, REF DYNJ909935;   d) NASAL SINUS-LF, REF DYNJ902624G;   e) ORAL, REF DYNJ902377I;   f) PACK,BRONCHOSCOPY, REF DYNJ65475B;   g) PACK,HEAD AND NECK, REF DYNJ65487B;   h) PACK,SINUS, REF DYNJ906898;   i) PACK,T & A, REF DYNJ906897B;   j) PACK,T & A ASC, REF DYNJ906914;   k) T AND A, REF DYNJ909941",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2703-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2703-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline medical procedure kits labeled as follows:      a) BASIC NASAL, REF DYNJ909932;   b) BRONCH KIT, REF DYKE1007B;   c) ENT, REF DYNJ909935;   d) NASAL SINUS-LF, REF DYNJ902624G;   e) ORAL, REF DYNJ902377I;   f) PACK,BRONCHOSCOPY, REF DYNJ65475B;   g) PACK,HEAD AND NECK, REF DYNJ65487B;   h) PACK,SINUS, REF DYNJ906898;   i) PACK,T & A, REF DYNJ906897B;   j) PACK,T & A ASC, REF DYNJ906914;   k) T AND A, REF DYNJ909941",
      "text": "The FDA logged enforcement record Z-2703-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline medical procedure kits labeled as follows:      a) BASIC NASAL, REF DYNJ909932;   b) BRONCH KIT, REF DYKE1007B;   c) ENT, REF DYNJ909935;   d) NASAL SINUS-LF, REF DYNJ902624G;   e) ORAL, REF DYNJ902377I;   f) PACK,BRONCHOSCOPY, REF DYNJ65475B;   g) PACK,HEAD AND NECK, REF DYNJ65487B;   h) PACK,SINUS, REF DYNJ906898;   i) PACK,T & A, REF DYNJ906897B;   j) PACK,T & A ASC, REF DYNJ906914;   k) T AND A, REF DYNJ909941 — reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-22. Affected lots/codes: a) REF DYNJ909932, UDI/DI 40195327511167 (case), 10195327511166 (unit), Lot Numbers:  23JBI290, 23KBI103;   b) REF DYKE1007B, UDI/DI 40195327203697 (case), 10195327203696 (unit), Lot Numbers:  22HBF709, 22HBV977, 22LBC080, 22LBH793, 23CBP363, 23DBL601, 23EBT148, 23FBS311, 23GBP583, 23HBY932, 23JBK265,;   c) REF DYNJ909935, UDI/DI 40195327511198 (case), 10195327511197 (unit), Lot Numbers:  23JBH869;   d) REF DYNJ902624G, UDI/DI 40195327214525 (case), 10195327214524 (unit), Lot Numbers:  22IBA877, 22IBN753, 23DBG397, 23FBN458, 23GBG939, 23HBT691, 23JBQ259, 23KBO185;   e) REF DYNJ902377I, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers:  23JBI663;   f) REF DYNJ65475B, UDI/DI 40195327303519 (case), 10195327303518 (unit), Lot Numbers:  22LBE939, 23ABK037, 23BBI110, 23CBH860, 23DBF474, 23DBS953, 23GBN857, 23JBE718, 23KBL576;   g) REF DYNJ65487B, UDI/DI 40195327303663 (case), 10195327303662 (unit), Lot Numbers:  22LBP408, 23ABN443, 23CBM523, 23DBM713, 23IBM894;   h) REF DYNJ906898, UDI/DI 40193489281928 (case), 10193489281927 (unit), Lot Numbers:  22HBA414, 22JBR764, 23FBK308, 23GBC593, 23IBF940, 23KBO165, 23KBT057;   i) REF DYNJ906897B, UDI/DI 40195327373147 (case), 10195327373146 (unit), Lot Numbers:  23EBE963, 23EBL760, 23FBC942, 23FBC943, 23HBQ553, 23HBS215, 23IBD903, 23KBE192, 23KBI100, 23LBH012;   j) REF DYNJ906914, UDI/DI 40193489280174 (case), 10193489280173 (unit), Lot Numbers:  22EBS455, 22EBU139, 22GBK146, 22HBG371, 22JBG419, 22KBI283, 23ABC387, 23CBI473, 23CBO589, 23CBU019, 23EBE957, 23EBV972, 23GBB581, 23IBP952, 23IBV288, 23JBB697, 23LBJ608;   k) REF DYNJ909941, UDI/DI 40195327511006 (case), 10195327511005 (unit), Lot Numbers:  23JBH984. 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-2703-2024&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-2703-2024&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-2703-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2703-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. 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-2703-2024&lang=eng",
        "value": "Class II",
        "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-2703-2024&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-2703-2024/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2703-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2703-2024",
            "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 II",
            "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": "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-03-22",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYNJ909932, UDI/DI 40195327511167 (case), 10195327511166 (unit), Lot Numbers:  23JBI290, 23KBI103;   b) REF DYKE1007B, UDI/DI 40195327203697 (case), 10195327203696 (unit), Lot Numbers:  22HBF709, 22HBV977, 22LBC080, 22LBH793, 23CBP363, 23DBL601, 23EBT148, 23FBS311, 23GBP583, 23HBY932, 23JBK265,;   c) REF DYNJ909935, UDI/DI 40195327511198 (case), 10195327511197 (unit), Lot Numbers:  23JBH869;   d) REF DYNJ902624G, UDI/DI 40195327214525 (case), 10195327214524 (unit), Lot Numbers:  22IBA877, 22IBN753, 23DBG397, 23FBN458, 23GBG939, 23HBT691, 23JBQ259, 23KBO185;   e) REF DYNJ902377I, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers:  23JBI663;   f) REF DYNJ65475B, UDI/DI 40195327303519 (case), 10195327303518 (unit), Lot Numbers:  22LBE939, 23ABK037, 23BBI110, 23CBH860, 23DBF474, 23DBS953, 23GBN857, 23JBE718, 23KBL576;   g) REF DYNJ65487B, UDI/DI 40195327303663 (case), 10195327303662 (unit), Lot Numbers:  22LBP408, 23ABN443, 23CBM523, 23DBM713, 23IBM894;   h) REF DYNJ906898, UDI/DI 40193489281928 (case), 10193489281927 (unit), Lot Numbers:  22HBA414, 22JBR764, 23FBK308, 23GBC593, 23IBF940, 23KBO165, 23KBT057;   i) REF DYNJ906897B, UDI/DI 40195327373147 (case), 10195327373146 (unit), Lot Numbers:  23EBE963, 23EBL760, 23FBC942, 23FBC943, 23HBQ553, 23HBS215, 23IBD903, 23KBE192, 23KBI100, 23LBH012;   j) REF DYNJ906914, UDI/DI 40193489280174 (case), 10193489280173 (unit), Lot Numbers:  22EBS455, 22EBU139, 22GBK146, 22HBG371, 22JBG419, 22KBI283, 23ABC387, 23CBI473, 23CBO589, 23CBU019, 23EBE957, 23EBV972, 23GBB581, 23IBP952, 23IBV288, 23JBB697, 23LBJ608;   k) REF DYNJ909941, UDI/DI 40195327511006 (case), 10195327511005 (unit), Lot Numbers:  23JBH984",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}