{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0150-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM",
  "description": "FDA recall Z-0150-2026 — BioPro, Inc. is recalling BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM (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-0150-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BioPro, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0150-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0150-2026: BioPro, Inc. is recalling BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM",
      "text": "The FDA logged enforcement record Z-0150-2026: BioPro, Inc. is voluntarily recalling BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM — 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  18130 M20918130 18131 M20918131 18132 M20918132 18133 M20918133 18134 M20918134 18135 M20918135 18136 M20918136 18137 M20918137 18138 M20918138 18139 M20918139 18140 M20918140 18141 M20918141 18142 M20918142 18143 M20918143 18144 M20918144 18145 M20918145 18146 M20918146 18147 M20918147 18148 M20918148 18149 M20918149 18150 M20918150 18151 M20918151 18152 M20918152  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-0150-2026&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-0150-2026&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-0150-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0150-2026 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-0150-2026&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-0150-2026&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-0150-2026/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": {
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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-0150-2026",
      "numberOfItems": 9,
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            "Value": "Z-0150-2026",
            "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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          "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  18130 M20918130 18131 M20918131 18132 M20918132 18133 M20918133 18134 M20918134 18135 M20918135 18136 M20918136 18137 M20918137 18138 M20918138 18139 M20918139 18140 M20918140 18141 M20918141 18142 M20918142 18143 M20918143 18144 M20918144 18145 M20918145 18146 M20918146 18147 M20918147 18148 M20918148 18149 M20918149 18150 M20918150 18151 M20918151 18152 M20918152  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"
          }
        }
      ]
    }
  ]
}