{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3092-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.",
  "description": "FDA recall Z-3092-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR. (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-3092-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3092-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3092-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.",
      "text": "The FDA logged enforcement record Z-3092-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR. — reason: Potential for an incomplete seal on the packaging tray.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-07. Affected lots/codes: Item Number: LF1837CR. UDI/DI: 20888277680392 (case), 10888277680395 (each). Lot Numbers: 487233, 487315, 487475, 487511, 499861, 499917, 500068, 500138, 500201, 500290, 500341, 500500, 500502, 500522, 500524, 500610, 500614, 500656, 500657, 507286, 507341, 507381, 507382, 507384, 507389, 507390, 507575, 513875, 514206, 514498, 514503, 514611, 514613, 514635, 514636, 514848, 514849, 514850, 514851, 514852, 514853, 514854, 514855, 514856, 515029, 515030, 515031, 515032, 515033, 515034, 515035, 515036, 515037, 515038, 515187, 515188, 515189, 515190, 515191, 515192, 515193, 515194, 515195, 515196, 515197, 515242, 515243, 515244, 515245, 515285, 515286, 515287, 515288, 515338, 515339, 515419, 515420, 515421, 515422, 515423, 515424, 515425, 515426, 515427, 515428, 515429, 515430, 515431, 515432, 515433, 515466, 515467, 515468, 515469, 515470, 515471, 515567, 515673, 515674, 515675, 515676, 515677, 515678, 515679, 515680, 515681, 515682, 515683, 515684, 515685, 515686, 515761, 515763, 515833, 515839, 515949, 515950, 515951, 516078, 516079, 516080, 516081, 516082, 516083, 516084, 516085, 516086, 516089, 516090, 516211, 516212, 516220, 516222, 516223, 516224, 516225, 516257, 516258, 516259, 516260, 516265, 516266, 516268, 516269, 516271, 516272, 516274, 516275, 516277, 516299, 516397, 516506, 516546, 516547, 516548, 516719, 516720, 516724, 516725, 516726, 516727, 516732, 516733, 516747, 516748, 516750, 516753, 516755, 516761, 516762, 516763, 516764, 516765, 516766, 516767, 516769, 516770, 516771, 516772, 516773, 516774, 516775, 516867, 516868, 516871, 516878, 516880, 517095, 517096, 517097, 517209, 517210, 517211, 517212, 517213, 517214, 517215, 517246, 517249, 517429, 517430, 517431, 517433, 517435, 517436, 517694, 517695, 517696, 517697, 517698, 517699, 517700, 517702, 517703, 517704, 517705, 517779, 517780, 517781, 517782, 517783, 517784, 517785, 517786, 517932, 518016, 518017, 518019, 518020, 518021, 518022, 518023, 518024, 518025, 518026, 518027, 518028, 518029, 518150, 518152, 518154, 518155, 518157, 518158, 518289, 518292, 518532, 518533, 518534, 518535, 518536, 518537, 518538, 518539, 518541, 518542, 518621, 518633, 518670, 518819, 518822, 518830.. 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-3092-2024&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-3092-2024&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-3092-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3092-2024 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-3092-2024&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-3092-2024&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-3092-2024/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-3092-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-3092-2024",
            "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": "Potential for an incomplete seal on the packaging tray.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-07",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Item Number: LF1837CR. UDI/DI: 20888277680392 (case), 10888277680395 (each). Lot Numbers: 487233, 487315, 487475, 487511, 499861, 499917, 500068, 500138, 500201, 500290, 500341, 500500, 500502, 500522, 500524, 500610, 500614, 500656, 500657, 507286, 507341, 507381, 507382, 507384, 507389, 507390, 507575, 513875, 514206, 514498, 514503, 514611, 514613, 514635, 514636, 514848, 514849, 514850, 514851, 514852, 514853, 514854, 514855, 514856, 515029, 515030, 515031, 515032, 515033, 515034, 515035, 515036, 515037, 515038, 515187, 515188, 515189, 515190, 515191, 515192, 515193, 515194, 515195, 515196, 515197, 515242, 515243, 515244, 515245, 515285, 515286, 515287, 515288, 515338, 515339, 515419, 515420, 515421, 515422, 515423, 515424, 515425, 515426, 515427, 515428, 515429, 515430, 515431, 515432, 515433, 515466, 515467, 515468, 515469, 515470, 515471, 515567, 515673, 515674, 515675, 515676, 515677, 515678, 515679, 515680, 515681, 515682, 515683, 515684, 515685, 515686, 515761, 515763, 515833, 515839, 515949, 515950, 515951, 516078, 516079, 516080, 516081, 516082, 516083, 516084, 516085, 516086, 516089, 516090, 516211, 516212, 516220, 516222, 516223, 516224, 516225, 516257, 516258, 516259, 516260, 516265, 516266, 516268, 516269, 516271, 516272, 516274, 516275, 516277, 516299, 516397, 516506, 516546, 516547, 516548, 516719, 516720, 516724, 516725, 516726, 516727, 516732, 516733, 516747, 516748, 516750, 516753, 516755, 516761, 516762, 516763, 516764, 516765, 516766, 516767, 516769, 516770, 516771, 516772, 516773, 516774, 516775, 516867, 516868, 516871, 516878, 516880, 517095, 517096, 517097, 517209, 517210, 517211, 517212, 517213, 517214, 517215, 517246, 517249, 517429, 517430, 517431, 517433, 517435, 517436, 517694, 517695, 517696, 517697, 517698, 517699, 517700, 517702, 517703, 517704, 517705, 517779, 517780, 517781, 517782, 517783, 517784, 517785, 517786, 517932, 518016, 518017, 518019, 518020, 518021, 518022, 518023, 518024, 518025, 518026, 518027, 518028, 518029, 518150, 518152, 518154, 518155, 518157, 518158, 518289, 518292, 518532, 518533, 518534, 518535, 518536, 518537, 518538, 518539, 518541, 518542, 518621, 518633, 518670, 518819, 518822, 518830.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}