{
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      "@id": "au:claims",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0149-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179\tENDO MD 38  10180\tENDO MD 41  10181\tENDO MD 43  10182\tENDO MD 45  10183\tENDO MD 47  10184\tENDO MD 49  10185\tENDO MD 51  10186\tENDO MD 53  10187\tENDO MD 55  10188\tENDO SH 38  10189\tENDO SH 41  10190\tENDO SH 43  10191\tENDO SH 45  10192\tENDO SH 47  10193\tENDO SH 49  10194\tENDO SH 51  10195\tENDO SH 53  10196\tENDO SH 55",
  "description": "FDA recall Z-0149-2026 — BioPro, Inc. is recalling BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179\tENDO MD 38  10180\tENDO MD 41  10181\tENDO MD 43  10182\tENDO MD 45  10183\tENDO MD 47  10184\tENDO MD 49  10185\tENDO MD 51  10186\tENDO MD 53  10187\tENDO MD 55  10188\tENDO SH 38  10189\tENDO SH 41  10190\tENDO SH 43  10191\tENDO SH 45  10192\tENDO SH 47  10193\tENDO SH 49  10194\tENDO SH 51  10195\tENDO SH 53  10196\tENDO SH 55 (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0149-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179\tENDO MD 38  10180\tENDO MD 41  10181\tENDO MD 43  10182\tENDO MD 45  10183\tENDO MD 47  10184\tENDO MD 49  10185\tENDO MD 51  10186\tENDO MD 53  10187\tENDO MD 55  10188\tENDO SH 38  10189\tENDO SH 41  10190\tENDO SH 43  10191\tENDO SH 45  10192\tENDO SH 47  10193\tENDO SH 49  10194\tENDO SH 51  10195\tENDO SH 53  10196\tENDO SH 55",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BioPro, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0149-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0149-2026: BioPro, Inc. is recalling BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179\tENDO MD 38  10180\tENDO MD 41  10181\tENDO MD 43  10182\tENDO MD 45  10183\tENDO MD 47  10184\tENDO MD 49  10185\tENDO MD 51  10186\tENDO MD 53  10187\tENDO MD 55  10188\tENDO SH 38  10189\tENDO SH 41  10190\tENDO SH 43  10191\tENDO SH 45  10192\tENDO SH 47  10193\tENDO SH 49  10194\tENDO SH 51  10195\tENDO SH 53  10196\tENDO SH 55",
      "text": "The FDA logged enforcement record Z-0149-2026: BioPro, Inc. is voluntarily recalling BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179\tENDO MD 38  10180\tENDO MD 41  10181\tENDO MD 43  10182\tENDO MD 45  10183\tENDO MD 47  10184\tENDO MD 49  10185\tENDO MD 51  10186\tENDO MD 53  10187\tENDO MD 55  10188\tENDO SH 38  10189\tENDO SH 41  10190\tENDO SH 43  10191\tENDO SH 45  10192\tENDO SH 47  10193\tENDO SH 49  10194\tENDO SH 51  10195\tENDO SH 53  10196\tENDO SH 55 — 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  10179 M20910179 10180 M20910180 10181 M20910181 10182 M20910182 10183 M20910183 10184 M20910184 10185 M20910185 10186 M20910186 10187 M20910187 10188 M20910188 10189 M20910189 10190 M20910190 10191 M20910191 10192 M20910192 10193 M20910193 10194 M20910194 10195 M20910195 10196 M20910196  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
      },
      "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-0149-2026&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-0149-2026&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-0149-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0149-2026 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-0149-2026&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-0149-2026&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-0149-2026/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",
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0149-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0149-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "BioPro, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product ID/UDI-DI  10179 M20910179 10180 M20910180 10181 M20910181 10182 M20910182 10183 M20910183 10184 M20910184 10185 M20910185 10186 M20910186 10187 M20910187 10188 M20910188 10189 M20910189 10190 M20910190 10191 M20910191 10192 M20910192 10193 M20910193 10194 M20910194 10195 M20910195 10196 M20910196  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"
          }
        }
      ]
    }
  ]
}