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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2660-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Veran Endobronchial:  Models:  INS-5925\tSPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes\t\t\t\t\t  INS-5920\tSPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes\t\t\t  INS-5915\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5910\tSPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes\t\t\t\t\t  INS-5905\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5900\tSPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes\t\t\t\t\t  INS-5700\tSPiN EWC Biopsy Guide Kit",
  "description": "FDA recall Z-2660-2023 — Olympus Corporation of the Americas is recalling Veran Endobronchial:  Models:  INS-5925\tSPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes\t\t\t\t\t  INS-5920\tSPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes\t\t\t  INS-5915\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5910\tSPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes\t\t\t\t\t  INS-5905\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5900\tSPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes\t\t\t\t\t  INS-5700\tSPiN EWC Biopsy Guide Kit (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/",
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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-2660-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Veran Endobronchial:  Models:  INS-5925\tSPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes\t\t\t\t\t  INS-5920\tSPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes\t\t\t  INS-5915\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5910\tSPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes\t\t\t\t\t  INS-5905\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5900\tSPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes\t\t\t\t\t  INS-5700\tSPiN EWC Biopsy Guide Kit",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2660-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2660-2023: Olympus Corporation of the Americas is recalling Veran Endobronchial:  Models:  INS-5925\tSPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes\t\t\t\t\t  INS-5920\tSPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes\t\t\t  INS-5915\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5910\tSPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes\t\t\t\t\t  INS-5905\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5900\tSPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes\t\t\t\t\t  INS-5700\tSPiN EWC Biopsy Guide Kit",
      "text": "The FDA logged enforcement record Z-2660-2023: Olympus Corporation of the Americas is voluntarily recalling Veran Endobronchial:  Models:  INS-5925\tSPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes\t\t\t\t\t  INS-5920\tSPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes\t\t\t  INS-5915\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5910\tSPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes\t\t\t\t\t  INS-5905\tSPiN Access Catheter¿ 180 for use w/ Olympus Scopes\t\t\t\t\t  INS-5900\tSPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes\t\t\t\t\t  INS-5700\tSPiN EWC Biopsy Guide Kit — reason: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)  manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-10. Affected lots/codes: Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes     00815686021313; INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes     00815686021306; INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes     00815686021290; INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes     00815686021276; INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes     00815686021269; INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes     00815686021153; INS-5700 SPiN EWC Biopsy Guide Kit  00815686021108.  All serial numbers and all lot numbers. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": 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-2660-2023&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-2660-2023&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-2660-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2660-2023 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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        "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-2660-2023&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-2660-2023/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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        "groundingType": "Interpretation",
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        "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-2660-2023",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2660-2023",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Olympus Corporation of the Americas",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)  manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-10",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model- UDI: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes     00815686021313; INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes     00815686021306; INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes     00815686021290; INS-5910 SPiN Access Catheter¿ 90 for use w/ Olympus 190 Scopes     00815686021276; INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes     00815686021269; INS-5900 SPiN Access Catheter¿ 90 Degree for use w/ Olympus Scopes     00815686021153; INS-5700 SPiN EWC Biopsy Guide Kit  00815686021108.  All serial numbers and all lot numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}