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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1683-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.  The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.",
  "description": "FDA recall Z-1683-2025 — Leica Biosystems Melbourne Pty Ltd is recalling HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.  The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples. (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,
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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-1683-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.  The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Leica Biosystems Melbourne Pty Ltd"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1683-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1683-2025: Leica Biosystems Melbourne Pty Ltd is recalling HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.  The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.",
      "text": "The FDA logged enforcement record Z-1683-2025: Leica Biosystems Melbourne Pty Ltd is voluntarily recalling HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0.  The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples. — reason: There is a leakage issue associated with the tubing in the manifold of the instrument.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-02. Affected lots/codes: UDI-DI: 09349458004811; Serial Numbers: 45111117, 45111154, 45111155, 45111156, 45111157, 45111158, 45111159, 45111160, 45111161, 45111162, 45111164, 45111166, 45111167, 45111168, 45111169, 45111170, 45111171, 45111174, 45111175, 45111176, 45111177, 45111178, 45111179, 45111180, 45111181, 45111182, 45111183.  08/12/2025 UPDATE: Additional Serial Numbers:  45111064, 45111065, 45111067, 45111068, 45111069, 45111070, 45111071, 45111073, 45111074, 45111075, 45111076, 45111077, 45111078, 45111079, 45111080, 45111081, 45111082, 45111084, 45111086, 45111087, 45111088, 45111089, 45111090, 45111091, 45111092, 45111093, 45111094, 45111095, 45111097, 45111098, 45111099, 45111100, 45111101, 45111102, 45111103, 45111104, 45111108, 45111109, 45111110, 45111111, 45111112, 45111113, 45111114, 45111115, 45111116,  45111120, 45111122, 45111123, 45111124, 45111125, 45111126, 45111127, 45111128, 45111129, 45111130, 45111131, 45111132, 45111133, 45111134, 45111135, 45111136, 45111137, 45111139,  45111140, 45111141, 45111142, 45111143, 45111144, 45111145, 45111146, 45111147, 45111148,  45111149, 45111150, 45111151, 45111152, 45111163.. 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-1683-2025&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-1683-2025&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-1683-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1683-2025 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-1683-2025&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-1683-2025&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-1683-2025/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
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      "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": [
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      "name": "FDA recall details — Z-1683-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1683-2025",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Leica Biosystems Melbourne Pty Ltd",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a leakage issue associated with the tubing in the manifold of the instrument.",
            "Status": "recorded"
          }
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        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-04-02",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 09349458004811; Serial Numbers: 45111117, 45111154, 45111155, 45111156, 45111157, 45111158, 45111159, 45111160, 45111161, 45111162, 45111164, 45111166, 45111167, 45111168, 45111169, 45111170, 45111171, 45111174, 45111175, 45111176, 45111177, 45111178, 45111179, 45111180, 45111181, 45111182, 45111183.  08/12/2025 UPDATE: Additional Serial Numbers:  45111064, 45111065, 45111067, 45111068, 45111069, 45111070, 45111071, 45111073, 45111074, 45111075, 45111076, 45111077, 45111078, 45111079, 45111080, 45111081, 45111082, 45111084, 45111086, 45111087, 45111088, 45111089, 45111090, 45111091, 45111092, 45111093, 45111094, 45111095, 45111097, 45111098, 45111099, 45111100, 45111101, 45111102, 45111103, 45111104, 45111108, 45111109, 45111110, 45111111, 45111112, 45111113, 45111114, 45111115, 45111116,  45111120, 45111122, 45111123, 45111124, 45111125, 45111126, 45111127, 45111128, 45111129, 45111130, 45111131, 45111132, 45111133, 45111134, 45111135, 45111136, 45111137, 45111139,  45111140, 45111141, 45111142, 45111143, 45111144, 45111145, 45111146, 45111147, 45111148,  45111149, 45111150, 45111151, 45111152, 45111163.",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.",
            "Status": "recorded"
          }
        }
      ]
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}