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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2149-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.  PRODUCT CODE:\t\t  MCP266H13  MCP3200H16  MCP3212H16  MCP3213H16  MCP340H13  MCP345H13  MCP416H14  MCP417H14  MCP426H13  MCP427H13  MCP4423H16  MCP4424H14  MCP442H14  MCP496H16  MCP497H16  MCP604H13  MCP936H13  MCP945H14  MCPB346H13",
  "description": "FDA recall Z-2149-2024 — Ethicon, Inc. is recalling MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.  PRODUCT CODE:\t\t  MCP266H13  MCP3200H16  MCP3212H16  MCP3213H16  MCP340H13  MCP345H13  MCP416H14  MCP417H14  MCP426H13  MCP427H13  MCP4423H16  MCP4424H14  MCP442H14  MCP496H16  MCP497H16  MCP604H13  MCP936H13  MCP945H14  MCPB346H13 (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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  "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-2149-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.  PRODUCT CODE:\t\t  MCP266H13  MCP3200H16  MCP3212H16  MCP3213H16  MCP340H13  MCP345H13  MCP416H14  MCP417H14  MCP426H13  MCP427H13  MCP4423H16  MCP4424H14  MCP442H14  MCP496H16  MCP497H16  MCP604H13  MCP936H13  MCP945H14  MCPB346H13",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Ethicon, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2149-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2149-2024: Ethicon, Inc. is recalling MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.  PRODUCT CODE:\t\t  MCP266H13  MCP3200H16  MCP3212H16  MCP3213H16  MCP340H13  MCP345H13  MCP416H14  MCP417H14  MCP426H13  MCP427H13  MCP4423H16  MCP4424H14  MCP442H14  MCP496H16  MCP497H16  MCP604H13  MCP936H13  MCP945H14  MCPB346H13",
      "text": "The FDA logged enforcement record Z-2149-2024: Ethicon, Inc. is voluntarily recalling MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated.  PRODUCT CODE:\t\t  MCP266H13  MCP3200H16  MCP3212H16  MCP3213H16  MCP340H13  MCP345H13  MCP416H14  MCP417H14  MCP426H13  MCP427H13  MCP4423H16  MCP4424H14  MCP442H14  MCP496H16  MCP497H16  MCP604H13  MCP936H13  MCP945H14  MCPB346H13 — reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-10. Affected lots/codes: GTIN: 10705031046337 10705031121393 10705031121423 10705031121430 10705031046405 10705031046429 10705031046481 10705031046498 10705031046504 10705031046511 10705031121997 10705031148116 10705031122000 10705031122314 10705031122338 10705031046634 10705031046757 10705031046795 10705031046863  Product Code    Lot Code MCP266H     UAMMCX               MCP340H     UAMQUZ               MCP416H     UBMHLB               MCP417H     UBMLKK               MCP426H     UAMLDQ   UAMRSL   UAMRUM                           UAMRUU   UAMRMR   UAMRUK                          UAMRMB               MCP427H     UAMLRK   UAMMCH   UAMLTR                          UAMKTS   UAMKQL   UAMREE         MCP604H     UAMLQE               MCP936H     UBMDQM   UBMDPZ   UBMEXS                           UBMQAR   UBMEQX   UBMKZA                           UBMLDR               MCP945H     UAMRKQ               MCPB346H    UAMQZB. 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-2149-2024&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-2149-2024&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-2149-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2149-2024 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
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-2149-2024&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-2149-2024/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",
      "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-2149-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2149-2024",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Ethicon, Inc.",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-10",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN: 10705031046337 10705031121393 10705031121423 10705031121430 10705031046405 10705031046429 10705031046481 10705031046498 10705031046504 10705031046511 10705031121997 10705031148116 10705031122000 10705031122314 10705031122338 10705031046634 10705031046757 10705031046795 10705031046863  Product Code    Lot Code MCP266H     UAMMCX               MCP340H     UAMQUZ               MCP416H     UBMHLB               MCP417H     UBMLKK               MCP426H     UAMLDQ   UAMRSL   UAMRUM                           UAMRUU   UAMRMR   UAMRUK                          UAMRMB               MCP427H     UAMLRK   UAMMCH   UAMLTR                          UAMKTS   UAMKQL   UAMREE         MCP604H     UAMLQE               MCP936H     UBMDQM   UBMDPZ   UBMEXS                           UBMQAR   UBMEQX   UBMKZA                           UBMLDR               MCP945H     UAMRKQ               MCPB346H    UAMQZB",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}