{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2148-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated  PRODUCT CODE:\t\t  Y315H\t\t\t\t  Y345H\t\t\t\t  Y359H\t\t\t\t  Y398H  Y416H\t\t\t\t  Y417H\t\t\t\t  Y426H\t\t\t  Y427H\t\t\t\t  Y935H\t\t\t  Y936H\t\t\t\t  Y945H",
  "description": "FDA recall Z-2148-2024 — Ethicon, Inc. is recalling MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated  PRODUCT CODE:\t\t  Y315H\t\t\t\t  Y345H\t\t\t\t  Y359H\t\t\t\t  Y398H  Y416H\t\t\t\t  Y417H\t\t\t\t  Y426H\t\t\t  Y427H\t\t\t\t  Y935H\t\t\t  Y936H\t\t\t\t  Y945H (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-2148-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated  PRODUCT CODE:\t\t  Y315H\t\t\t\t  Y345H\t\t\t\t  Y359H\t\t\t\t  Y398H  Y416H\t\t\t\t  Y417H\t\t\t\t  Y426H\t\t\t  Y427H\t\t\t\t  Y935H\t\t\t  Y936H\t\t\t\t  Y945H",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Ethicon, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2148-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2148-2024: Ethicon, Inc. is recalling MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated  PRODUCT CODE:\t\t  Y315H\t\t\t\t  Y345H\t\t\t\t  Y359H\t\t\t\t  Y398H  Y416H\t\t\t\t  Y417H\t\t\t\t  Y426H\t\t\t  Y427H\t\t\t\t  Y935H\t\t\t  Y936H\t\t\t\t  Y945H",
      "text": "The FDA logged enforcement record Z-2148-2024: Ethicon, Inc. is voluntarily recalling MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated  PRODUCT CODE:\t\t  Y315H\t\t\t\t  Y345H\t\t\t\t  Y359H\t\t\t\t  Y398H  Y416H\t\t\t\t  Y417H\t\t\t\t  Y426H\t\t\t  Y427H\t\t\t\t  Y935H\t\t\t  Y936H\t\t\t\t  Y945H — 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: GTIN 10705031058729 10705031058897 10705031059047 10705031059092 10705031059122 30705031059133     10705031112674 10705031059146 10705031059153 10705031059245 10705031059894 10705031059917 10705031059962   PRODUCT CODE   PRODUCT LOTS                 Y315H     UAMQCX               Y345H     UBMCAJ               Y359H     UBMHQS               Y398H     UAMLMU   UAMPJB   UAMMXQ                   UBMJPB   UBMQQR            Y416H     UAMLQM   UAMLKM   UAMRMZ         Y417H     UCMEDU               Y426H     UAMKCL   UAMKHE   UAMPQS                    UBMJTE               Y427H     UAMLXX   UAMMJR   UAMPSC         Y935H     UBMCAA   UBMDKJ   UBMDKC                    UBMHDD               Y936H     UBMJQM               Y945H     UAMKCD. 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-2148-2024&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-2148-2024&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-2148-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2148-2024 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": {
        "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-2148-2024&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-2148-2024&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-2148-2024/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-2148-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2148-2024",
            "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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        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "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: GTIN 10705031058729 10705031058897 10705031059047 10705031059092 10705031059122 30705031059133     10705031112674 10705031059146 10705031059153 10705031059245 10705031059894 10705031059917 10705031059962   PRODUCT CODE   PRODUCT LOTS                 Y315H     UAMQCX               Y345H     UBMCAJ               Y359H     UBMHQS               Y398H     UAMLMU   UAMPJB   UAMMXQ                   UBMJPB   UBMQQR            Y416H     UAMLQM   UAMLKM   UAMRMZ         Y417H     UCMEDU               Y426H     UAMKCL   UAMKHE   UAMPQS                    UBMJTE               Y427H     UAMLXX   UAMMJR   UAMPSC         Y935H     UBMCAA   UBMDKJ   UBMDKC                    UBMHDD               Y936H     UBMJQM               Y945H     UAMKCD",
            "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"
          }
        }
      ]
    }
  ]
}