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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2144-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:\t\t  J214H\t\t  J218H\t\t  J258H\t\t  J268H\t\t  J269H\t\t  J327H\t\t  J344H\t\t  J345H\t\t  J370H\t\t  J416H\t\t  J417H\t\t  J426H\t\t  \t\t  J427H\t\t  J458H\t\t  J493H\t\t  J603H\t\t  J699H\t\t  J936H\t\t  J978H",
  "description": "FDA recall Z-2144-2024 — Ethicon, Inc. is recalling VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:\t\t  J214H\t\t  J218H\t\t  J258H\t\t  J268H\t\t  J269H\t\t  J327H\t\t  J344H\t\t  J345H\t\t  J370H\t\t  J416H\t\t  J417H\t\t  J426H\t\t  \t\t  J427H\t\t  J458H\t\t  J493H\t\t  J603H\t\t  J699H\t\t  J936H\t\t  J978H (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",
  "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-2144-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:\t\t  J214H\t\t  J218H\t\t  J258H\t\t  J268H\t\t  J269H\t\t  J327H\t\t  J344H\t\t  J345H\t\t  J370H\t\t  J416H\t\t  J417H\t\t  J426H\t\t  \t\t  J427H\t\t  J458H\t\t  J493H\t\t  J603H\t\t  J699H\t\t  J936H\t\t  J978H",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Ethicon, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2144-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2144-2024: Ethicon, Inc. is recalling VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:\t\t  J214H\t\t  J218H\t\t  J258H\t\t  J268H\t\t  J269H\t\t  J327H\t\t  J344H\t\t  J345H\t\t  J370H\t\t  J416H\t\t  J417H\t\t  J426H\t\t  \t\t  J427H\t\t  J458H\t\t  J493H\t\t  J603H\t\t  J699H\t\t  J936H\t\t  J978H",
      "text": "The FDA logged enforcement record Z-2144-2024: Ethicon, Inc. is voluntarily recalling VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:\t\t  J214H\t\t  J218H\t\t  J258H\t\t  J268H\t\t  J269H\t\t  J327H\t\t  J344H\t\t  J345H\t\t  J370H\t\t  J416H\t\t  J417H\t\t  J426H\t\t  \t\t  J427H\t\t  J458H\t\t  J493H\t\t  J603H\t\t  J699H\t\t  J936H\t\t  J978H — 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: UDI-DI: N/A PRODUCT CODE   PRODUCT LOTS                 J214H   UAMPJQ                 J218H   UBMJSK                 J258H   UBMHSJ                 J268H   UBMLPP                 J269H   UAMMAH   UAMRMU              J327H   UAMPEP                 J344H   UBMHRU                 J345H   UAMJPK   UAMPKD              J370H   UAMMJT                 J416H   UAMRSJ   UAMRHB              J417H   UAMLMX                 J426H   UAMQRQ   UBMCAC        UBMCML         UBMCRD                 J427H   UAMRPR                 J458H   UAMQRT                 J493H   UAMMKE                 J603H   TPMBSX   UAMLXC        UAMMBQ      J699H   UAMQME                 J936H   UAMMSL                 J978H   UAMKBD   UAMHTE. 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-2144-2024&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-2144-2024&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-2144-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2144-2024 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,
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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-2144-2024&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-2144-2024&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-2144-2024/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2144-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2144-2024",
            "Status": "recorded"
          }
        },
        {
          "@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": "UDI-DI: N/A PRODUCT CODE   PRODUCT LOTS                 J214H   UAMPJQ                 J218H   UBMJSK                 J258H   UBMHSJ                 J268H   UBMLPP                 J269H   UAMMAH   UAMRMU              J327H   UAMPEP                 J344H   UBMHRU                 J345H   UAMJPK   UAMPKD              J370H   UAMMJT                 J416H   UAMRSJ   UAMRHB              J417H   UAMLMX                 J426H   UAMQRQ   UBMCAC        UBMCML         UBMCRD                 J427H   UAMRPR                 J458H   UAMQRT                 J493H   UAMMKE                 J603H   TPMBSX   UAMLXC        UAMMBQ      J699H   UAMQME                 J936H   UAMMSL                 J978H   UAMKBD   UAMHTE",
            "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"
          }
        }
      ]
    }
  ]
}