{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1449-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Centurion Manual surgical kits labeled as:    a) STERILE S/B WIRE SCISSOR, Product Code 65140;   b) SHARP/SHARP SCISSORS 41/2\", Product Code 65840;   c) STERILE WIRE CUTTER (WCS144), Product Code 66240;   d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855;   e) STERILE UTILITY SHEARS (USH176), Product Code 67225;   f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670",
  "description": "FDA recall Z-1449-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion Manual surgical kits labeled as:    a) STERILE S/B WIRE SCISSOR, Product Code 65140;   b) SHARP/SHARP SCISSORS 41/2\", Product Code 65840;   c) STERILE WIRE CUTTER (WCS144), Product Code 66240;   d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855;   e) STERILE UTILITY SHEARS (USH176), Product Code 67225;   f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670 (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-1449-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centurion Manual surgical kits labeled as:    a) STERILE S/B WIRE SCISSOR, Product Code 65140;   b) SHARP/SHARP SCISSORS 41/2\", Product Code 65840;   c) STERILE WIRE CUTTER (WCS144), Product Code 66240;   d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855;   e) STERILE UTILITY SHEARS (USH176), Product Code 67225;   f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1449-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1449-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion Manual surgical kits labeled as:    a) STERILE S/B WIRE SCISSOR, Product Code 65140;   b) SHARP/SHARP SCISSORS 41/2\", Product Code 65840;   c) STERILE WIRE CUTTER (WCS144), Product Code 66240;   d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855;   e) STERILE UTILITY SHEARS (USH176), Product Code 67225;   f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670",
      "text": "The FDA logged enforcement record Z-1449-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Centurion Manual surgical kits labeled as:    a) STERILE S/B WIRE SCISSOR, Product Code 65140;   b) SHARP/SHARP SCISSORS 41/2\", Product Code 65840;   c) STERILE WIRE CUTTER (WCS144), Product Code 66240;   d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855;   e) STERILE UTILITY SHEARS (USH176), Product Code 67225;   f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670 — reason: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-23. Affected lots/codes: a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers:  2023060790, 2023101090;   b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers:  2023022790, 2023041190;   c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers:  2023112790;   d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers:  2023022490, 2023041990, 2023102690;   e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers:  2023031690, 2023111490;   f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers:  2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990. 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-1449-2024&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-1449-2024&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-1449-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1449-2024 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)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1449-2024&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-1449-2024&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-1449-2024/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-1449-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1449-2024",
            "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"
          }
        },
        {
          "@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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-02-23",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers:  2023060790, 2023101090;   b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers:  2023022790, 2023041190;   c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers:  2023112790;   d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers:  2023022490, 2023041990, 2023102690;   e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers:  2023031690, 2023111490;   f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers:  2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Panama, Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}