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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3206-2024.jsonld",
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  "name": "BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:  MN1410  MN 1420  MN1610  MN1616  MN1820  MN2010    The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.",
  "description": "FDA recall Z-3206-2024 — Bard Peripheral Vascular Inc is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:  MN1410  MN 1420  MN1610  MN1616  MN1820  MN2010    The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "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-3206-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:  MN1410  MN 1420  MN1610  MN1616  MN1820  MN2010    The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Bard Peripheral Vascular Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3206-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3206-2024: Bard Peripheral Vascular Inc is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:  MN1410  MN 1420  MN1610  MN1616  MN1820  MN2010    The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.",
      "text": "The FDA logged enforcement record Z-3206-2024: Bard Peripheral Vascular Inc is voluntarily recalling BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:  MN1410  MN 1420  MN1610  MN1616  MN1820  MN2010    The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. — reason: Due to possible packaging damage (indentations/cuts) cause by manufacturing process.  As a result of the packaging damage, may cause the sterile barrier to be compromised.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-02. Affected lots/codes: Product Name: Magnum 14g x 10cm Catalog Number: MN1410 Lot Numbers / UDI code: REJP3295 / (01)00801741084249(17)270131(10)REJP3295 REJP2228 / (01)00801741084249(17)270131(10)REJP2228 REJN2583 / (01)00801741084249(17)261231(10)REJN2583 REJQ2851 / (01)00801741084249(17)270228(10)REJQ2851 REJQ0831 / (01)00801741084249(17)270228(10)REJQ0831  Product Name: Magnum 14g x 20cm Catalog Number: MN1420 Lot Numbers / UDI code: REHX2867 / (01)00801741084270(17)260930(10)REHX2867  Product Name: Magnum 16g x 10cm Catalog Number: MN1610 Lot Numbers / UDI code: REJN0587 / (01)00801741084287(17)261231(10)REJN0587  Product Name: Magnum 16g x 16cm Catalog Number: MN1616 Lot Numbers / UDI code: REJP3289 / (01)00801741084300(17)270131(10)REJP3289  Product Name: Magnum 18g x 20cm Catalog Number: MN1820 Lot Numbers / UDI code: REJS1418 / (01)00801741084355(17)270430(10)REJS1418  Product Name: Magnum 20g x 10cm Catalog Number: MN2010 Lot Numbers / UDI code: REJQ1160 / (01)00801741084386(17)270228(10)REJQ1160. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "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-3206-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-3206-2024&lang=eng"
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      },
      "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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3206-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3206-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "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-3206-2024&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-3206-2024&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-3206-2024/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",
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      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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-3206-2024",
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            "Field": "Recall number",
            "Value": "Z-3206-2024",
            "Status": "recorded"
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          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Bard Peripheral Vascular Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to possible packaging damage (indentations/cuts) cause by manufacturing process.  As a result of the packaging damage, may cause the sterile barrier to be compromised.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-02",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product Name: Magnum 14g x 10cm Catalog Number: MN1410 Lot Numbers / UDI code: REJP3295 / (01)00801741084249(17)270131(10)REJP3295 REJP2228 / (01)00801741084249(17)270131(10)REJP2228 REJN2583 / (01)00801741084249(17)261231(10)REJN2583 REJQ2851 / (01)00801741084249(17)270228(10)REJQ2851 REJQ0831 / (01)00801741084249(17)270228(10)REJQ0831  Product Name: Magnum 14g x 20cm Catalog Number: MN1420 Lot Numbers / UDI code: REHX2867 / (01)00801741084270(17)260930(10)REHX2867  Product Name: Magnum 16g x 10cm Catalog Number: MN1610 Lot Numbers / UDI code: REJN0587 / (01)00801741084287(17)261231(10)REJN0587  Product Name: Magnum 16g x 16cm Catalog Number: MN1616 Lot Numbers / UDI code: REJP3289 / (01)00801741084300(17)270131(10)REJP3289  Product Name: Magnum 18g x 20cm Catalog Number: MN1820 Lot Numbers / UDI code: REJS1418 / (01)00801741084355(17)270430(10)REJS1418  Product Name: Magnum 20g x 10cm Catalog Number: MN2010 Lot Numbers / UDI code: REJQ1160 / (01)00801741084386(17)270228(10)REJQ1160",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.",
            "Status": "recorded"
          }
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}