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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0834-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON  Endopath Stapler, Endoscopic Linear Cutter Reload  (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W",
  "description": "FDA recall Z-0834-2024 — Ethicon Endo-Surgery Inc is recalling ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON  Endopath Stapler, Endoscopic Linear Cutter Reload  (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W (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",
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    "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-0834-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON  Endopath Stapler, Endoscopic Linear Cutter Reload  (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Ethicon Endo-Surgery Inc"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0834-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0834-2024: Ethicon Endo-Surgery Inc is recalling ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON  Endopath Stapler, Endoscopic Linear Cutter Reload  (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W",
      "text": "The FDA logged enforcement record Z-0834-2024: Ethicon Endo-Surgery Inc is voluntarily recalling ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON  Endopath Stapler, Endoscopic Linear Cutter Reload  (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W — reason: There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-11. Affected lots/codes: UDI-DI 10705036014928 Lots 442C02 and 442C03. 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-0834-2024&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-0834-2024&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-0834-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0834-2024 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.",
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        "supported": true,
        "adjudged": true,
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        "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-0834-2024&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-0834-2024/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,
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        "adjudged": false,
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        "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-0834-2024",
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            "Value": "Z-0834-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Ethicon Endo-Surgery Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-12-11",
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            "Value": "UDI-DI 10705036014928 Lots 442C02 and 442C03",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada and Brazil.",
            "Status": "recorded"
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