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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2664-2023.jsonld",
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  "name": "Veran : Endobronchial Always on Track  Models:  INS-0392\tAOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX\t\t\t\t\t  INS-0382\tAOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx\t\t\t\t\t  INS-0372\tAOTT Serrated Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0362\tAOTT Oval Cup Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0352\t\"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"\t\t\t\t\t  INS-0322\tView Peripheral Catheter, 3.2mm OD, 2.0mm WC\t\t\t\t\t  INS-0305\tAlways-On Tip Tracked Guidewire, 1.0mm, 950mm\t\t\t\t\t  INS-0304\tAlways-On Tip Tracked Guidewire, 1.0mm, 735mm\t\t\t\t\t  INS-0050\tvPad Patient Tracker, 5/Bx\t\t\t\t\t  INS-0048\tvPad Connector Cable",
  "description": "FDA recall Z-2664-2023 — Olympus Corporation of the Americas is recalling Veran : Endobronchial Always on Track  Models:  INS-0392\tAOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX\t\t\t\t\t  INS-0382\tAOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx\t\t\t\t\t  INS-0372\tAOTT Serrated Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0362\tAOTT Oval Cup Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0352\t\"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"\t\t\t\t\t  INS-0322\tView Peripheral Catheter, 3.2mm OD, 2.0mm WC\t\t\t\t\t  INS-0305\tAlways-On Tip Tracked Guidewire, 1.0mm, 950mm\t\t\t\t\t  INS-0304\tAlways-On Tip Tracked Guidewire, 1.0mm, 735mm\t\t\t\t\t  INS-0050\tvPad Patient Tracker, 5/Bx\t\t\t\t\t  INS-0048\tvPad Connector Cable (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Veran : Endobronchial Always on Track  Models:  INS-0392\tAOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX\t\t\t\t\t  INS-0382\tAOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx\t\t\t\t\t  INS-0372\tAOTT Serrated Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0362\tAOTT Oval Cup Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0352\t\"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"\t\t\t\t\t  INS-0322\tView Peripheral Catheter, 3.2mm OD, 2.0mm WC\t\t\t\t\t  INS-0305\tAlways-On Tip Tracked Guidewire, 1.0mm, 950mm\t\t\t\t\t  INS-0304\tAlways-On Tip Tracked Guidewire, 1.0mm, 735mm\t\t\t\t\t  INS-0050\tvPad Patient Tracker, 5/Bx\t\t\t\t\t  INS-0048\tvPad Connector Cable",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2664-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2664-2023: Olympus Corporation of the Americas is recalling Veran : Endobronchial Always on Track  Models:  INS-0392\tAOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX\t\t\t\t\t  INS-0382\tAOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx\t\t\t\t\t  INS-0372\tAOTT Serrated Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0362\tAOTT Oval Cup Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0352\t\"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"\t\t\t\t\t  INS-0322\tView Peripheral Catheter, 3.2mm OD, 2.0mm WC\t\t\t\t\t  INS-0305\tAlways-On Tip Tracked Guidewire, 1.0mm, 950mm\t\t\t\t\t  INS-0304\tAlways-On Tip Tracked Guidewire, 1.0mm, 735mm\t\t\t\t\t  INS-0050\tvPad Patient Tracker, 5/Bx\t\t\t\t\t  INS-0048\tvPad Connector Cable",
      "text": "The FDA logged enforcement record Z-2664-2023: Olympus Corporation of the Americas is voluntarily recalling Veran : Endobronchial Always on Track  Models:  INS-0392\tAOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX\t\t\t\t\t  INS-0382\tAOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx\t\t\t\t\t  INS-0372\tAOTT Serrated Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0362\tAOTT Oval Cup Forceps, 1.8mm OD, 5/Bx\t\t\t\t\t  INS-0352\t\"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"\t\t\t\t\t  INS-0322\tView Peripheral Catheter, 3.2mm OD, 2.0mm WC\t\t\t\t\t  INS-0305\tAlways-On Tip Tracked Guidewire, 1.0mm, 950mm\t\t\t\t\t  INS-0304\tAlways-On Tip Tracked Guidewire, 1.0mm, 735mm\t\t\t\t\t  INS-0050\tvPad Patient Tracker, 5/Bx\t\t\t\t\t  INS-0048\tvPad Connector Cable — 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: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX   00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx     00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx     00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx     00815686020538; INS-0352 \"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"   00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC     00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm     00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm     00815686020439; INS-0050 vPad Patient Tracker, 5/Bx   00815686020408; INS-0048 vPad Connector Cable    00815686020392;   All serial numbers and all lot numbers. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "adjudged": 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-2664-2023&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-2664-2023&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-2664-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2664-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": false,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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-2664-2023&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-2664-2023/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",
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      "epistemicStatus": {
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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-2664-2023",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2664-2023",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        {
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          "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": "Olympus Corporation of the Americas",
            "Status": "recorded"
          }
        },
        {
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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"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX   00815686020613; INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx     00815686020590; INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx     00815686020576; INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx     00815686020538; INS-0352 \"Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx\"   00815686020538; INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC     00815686020477; INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm     00815686020446; INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm     00815686020439; INS-0050 vPad Patient Tracker, 5/Bx   00815686020408; INS-0048 vPad Connector Cable    00815686020392;   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"
          }
        }
      ]
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}