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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0844-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT",
  "description": "FDA recall Z-0844-2024 — Covidien LP is recalling Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0844-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Covidien LP"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0844-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0844-2024: Covidien LP is recalling Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT",
      "text": "The FDA logged enforcement record Z-0844-2024: Covidien LP is voluntarily recalling Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT — reason: Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-21. Affected lots/codes: Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY  Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 Lot D2B0176RY  Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY  Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-0844-2024&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-0844-2024&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-0844-2024/fda-classification",
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      "name": "FDA classified recall Z-0844-2024 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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        "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-0844-2024&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-0844-2024/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": {
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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-0844-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0844-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "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": "Covidien LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-12-21",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY  Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 Lot D2B0176RY  Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY  Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide   US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.",
            "Status": "recorded"
          }
        }
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}