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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0152-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "BioPro Endo Head (Ceramic)    Product ID/Description  13006\tENDO MODULAR CERAMIC SH 38  13012\tENDO MODULAR CERAMIC SH 51  13013\tENDO MODULAR CERAMIC MD 38  13019\tENDO MODULAR CERAMIC MD 51  13007\tENDO MODULAR CERAMIC SH 41  13008\tENDO MODULAR CERAMIC SH 43  13009\tENDO MODULAR CERAMIC SH 45  13010\tENDO MODULAR CERAMIC SH 47  13011\tENDO MODULAR CERAMIC SH 49  13014\tENDO MODULAR CERAMIC MD 41  13015\tENDO MODULAR CERAMIC MD 43  13016\tENDO MODULAR CERAMIC MD 45  13017\tENDO MODULAR CERAMIC MD 47  13018\tENDO MODULAR CERAMIC MD 49  14823\tENDO MODULAR CERAMIC SH 53  14824\tENDO MODULAR CERAMIC MD 53  14825\tENDO MODULAR CERAMIC SH 55  14826\tENDO MODULAR CERAMIC MD 55  17295\tENDO MODULAR CERAMIC SH 36  17296\tENDO MODULAR CERAMIC MD 36",
  "description": "FDA recall Z-0152-2026 — BioPro, Inc. is recalling BioPro Endo Head (Ceramic)    Product ID/Description  13006\tENDO MODULAR CERAMIC SH 38  13012\tENDO MODULAR CERAMIC SH 51  13013\tENDO MODULAR CERAMIC MD 38  13019\tENDO MODULAR CERAMIC MD 51  13007\tENDO MODULAR CERAMIC SH 41  13008\tENDO MODULAR CERAMIC SH 43  13009\tENDO MODULAR CERAMIC SH 45  13010\tENDO MODULAR CERAMIC SH 47  13011\tENDO MODULAR CERAMIC SH 49  13014\tENDO MODULAR CERAMIC MD 41  13015\tENDO MODULAR CERAMIC MD 43  13016\tENDO MODULAR CERAMIC MD 45  13017\tENDO MODULAR CERAMIC MD 47  13018\tENDO MODULAR CERAMIC MD 49  14823\tENDO MODULAR CERAMIC SH 53  14824\tENDO MODULAR CERAMIC MD 53  14825\tENDO MODULAR CERAMIC SH 55  14826\tENDO MODULAR CERAMIC MD 55  17295\tENDO MODULAR CERAMIC SH 36  17296\tENDO MODULAR CERAMIC MD 36 (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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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-0152-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BioPro Endo Head (Ceramic)    Product ID/Description  13006\tENDO MODULAR CERAMIC SH 38  13012\tENDO MODULAR CERAMIC SH 51  13013\tENDO MODULAR CERAMIC MD 38  13019\tENDO MODULAR CERAMIC MD 51  13007\tENDO MODULAR CERAMIC SH 41  13008\tENDO MODULAR CERAMIC SH 43  13009\tENDO MODULAR CERAMIC SH 45  13010\tENDO MODULAR CERAMIC SH 47  13011\tENDO MODULAR CERAMIC SH 49  13014\tENDO MODULAR CERAMIC MD 41  13015\tENDO MODULAR CERAMIC MD 43  13016\tENDO MODULAR CERAMIC MD 45  13017\tENDO MODULAR CERAMIC MD 47  13018\tENDO MODULAR CERAMIC MD 49  14823\tENDO MODULAR CERAMIC SH 53  14824\tENDO MODULAR CERAMIC MD 53  14825\tENDO MODULAR CERAMIC SH 55  14826\tENDO MODULAR CERAMIC MD 55  17295\tENDO MODULAR CERAMIC SH 36  17296\tENDO MODULAR CERAMIC MD 36",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BioPro, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0152-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0152-2026: BioPro, Inc. is recalling BioPro Endo Head (Ceramic)    Product ID/Description  13006\tENDO MODULAR CERAMIC SH 38  13012\tENDO MODULAR CERAMIC SH 51  13013\tENDO MODULAR CERAMIC MD 38  13019\tENDO MODULAR CERAMIC MD 51  13007\tENDO MODULAR CERAMIC SH 41  13008\tENDO MODULAR CERAMIC SH 43  13009\tENDO MODULAR CERAMIC SH 45  13010\tENDO MODULAR CERAMIC SH 47  13011\tENDO MODULAR CERAMIC SH 49  13014\tENDO MODULAR CERAMIC MD 41  13015\tENDO MODULAR CERAMIC MD 43  13016\tENDO MODULAR CERAMIC MD 45  13017\tENDO MODULAR CERAMIC MD 47  13018\tENDO MODULAR CERAMIC MD 49  14823\tENDO MODULAR CERAMIC SH 53  14824\tENDO MODULAR CERAMIC MD 53  14825\tENDO MODULAR CERAMIC SH 55  14826\tENDO MODULAR CERAMIC MD 55  17295\tENDO MODULAR CERAMIC SH 36  17296\tENDO MODULAR CERAMIC MD 36",
      "text": "The FDA logged enforcement record Z-0152-2026: BioPro, Inc. is voluntarily recalling BioPro Endo Head (Ceramic)    Product ID/Description  13006\tENDO MODULAR CERAMIC SH 38  13012\tENDO MODULAR CERAMIC SH 51  13013\tENDO MODULAR CERAMIC MD 38  13019\tENDO MODULAR CERAMIC MD 51  13007\tENDO MODULAR CERAMIC SH 41  13008\tENDO MODULAR CERAMIC SH 43  13009\tENDO MODULAR CERAMIC SH 45  13010\tENDO MODULAR CERAMIC SH 47  13011\tENDO MODULAR CERAMIC SH 49  13014\tENDO MODULAR CERAMIC MD 41  13015\tENDO MODULAR CERAMIC MD 43  13016\tENDO MODULAR CERAMIC MD 45  13017\tENDO MODULAR CERAMIC MD 47  13018\tENDO MODULAR CERAMIC MD 49  14823\tENDO MODULAR CERAMIC SH 53  14824\tENDO MODULAR CERAMIC MD 53  14825\tENDO MODULAR CERAMIC SH 55  14826\tENDO MODULAR CERAMIC MD 55  17295\tENDO MODULAR CERAMIC SH 36  17296\tENDO MODULAR CERAMIC MD 36 — reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-09. Affected lots/codes: Product ID/UDI-DI  13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296  All lots, all serial numbers. 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-0152-2026&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-0152-2026&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-0152-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0152-2026 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-0152-2026&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-0152-2026&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-0152-2026/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",
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      "epistemicStatus": {
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        "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-0152-2026",
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            "Value": "Z-0152-2026",
            "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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          "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": "BioPro, Inc.",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-09",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product ID/UDI-DI  13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296  All lots, all serial numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Domestic distribution to Texas and Michigan.",
            "Status": "recorded"
          }
        }
      ]
    }
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}