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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1900-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: EsophaCap  Product Name: EsophaCap (25mm diameter, 10 pores/inch)  Model/Catalog Number: EC25T10VI  Software Version: N/A  Product Description: EsophaCap is pouched as individual units.  10 units go into a shelf-box.  Component: N/A",
  "description": "FDA recall Z-1900-2024 — Lucid Diagnostics, Inc. is recalling Brand Name: EsophaCap  Product Name: EsophaCap (25mm diameter, 10 pores/inch)  Model/Catalog Number: EC25T10VI  Software Version: N/A  Product Description: EsophaCap is pouched as individual units.  10 units go into a shelf-box.  Component: N/A (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1900-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: EsophaCap  Product Name: EsophaCap (25mm diameter, 10 pores/inch)  Model/Catalog Number: EC25T10VI  Software Version: N/A  Product Description: EsophaCap is pouched as individual units.  10 units go into a shelf-box.  Component: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Lucid Diagnostics, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1900-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1900-2024: Lucid Diagnostics, Inc. is recalling Brand Name: EsophaCap  Product Name: EsophaCap (25mm diameter, 10 pores/inch)  Model/Catalog Number: EC25T10VI  Software Version: N/A  Product Description: EsophaCap is pouched as individual units.  10 units go into a shelf-box.  Component: N/A",
      "text": "The FDA logged enforcement record Z-1900-2024: Lucid Diagnostics, Inc. is voluntarily recalling Brand Name: EsophaCap  Product Name: EsophaCap (25mm diameter, 10 pores/inch)  Model/Catalog Number: EC25T10VI  Software Version: N/A  Product Description: EsophaCap is pouched as individual units.  10 units go into a shelf-box.  Component: N/A — reason: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-24. Affected lots/codes: Lot Code: Product sent out to clinical site:  Part #:  EC25T10VI ; GTIN Number:  00860007510977 ; Lot #'s:  483 (Qty: 120), 502 (Qty: 100)  Product at Distributor in Quarantine:  Part #:  EC25T10VI ; GTIN Number:  00860007510977 ; Lot #'s:  539 (Qty: 99). 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-1900-2024&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-1900-2024&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-1900-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1900-2024 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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      "reviewStatus": "current",
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        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-1900-2024&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-1900-2024&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-1900-2024/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."
    }
  ],
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      "name": "FDA recall details — Z-1900-2024",
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            "Value": "Z-1900-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "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": "Lucid Diagnostics, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-04-24",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Lot Code: Product sent out to clinical site:  Part #:  EC25T10VI ; GTIN Number:  00860007510977 ; Lot #'s:  483 (Qty: 120), 502 (Qty: 100)  Product at Distributor in Quarantine:  Part #:  EC25T10VI ; GTIN Number:  00860007510977 ; Lot #'s:  539 (Qty: 99)",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of MN, MD.",
            "Status": "recorded"
          }
        }
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}