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  "name": "Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.",
  "description": "FDA recall Z-2045-2026 — Medline Industries, LP is recalling Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A. (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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      "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-2045-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2045-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2045-2026: Medline Industries, LP is recalling Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.",
      "text": "The FDA logged enforcement record Z-2045-2026: Medline Industries, LP is voluntarily recalling Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A. — reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-16. Affected lots/codes: Medline Kit SKU DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090;  Medline Kit SKU IVS1975A:  UDI/DI each 10653160327936, UDI/DI case 00653160327939, Lot Number: 2025100890;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2025103190;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2025110590;  Medline Kit SKU DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025110790;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2025111990;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2025112490;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2025120990;  Medline Kit SKU DM100:  UDI/DI each 10653160280101, UDI/DI case 00653160280104, Lot Number: 2026010690;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2026011390;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2026011390;  Medline Kit SKU DT7340:  UDI/DI each 00653160091427, UDI/DI case 50653160091422, Lot Number: 2026021090;  Medline Kit SKU DM660:  UDI/DI each 10653160290667, UDI/DI case 00653160290660, Lot Number: 2026020690;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2026020990;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2026021290;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2026021790;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2025121990;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2026020990.. 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-2045-2026&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-2045-2026&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-2045-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2045-2026 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": {
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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-2045-2026&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-2045-2026/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."
    }
  ],
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      "name": "FDA recall details — Z-2045-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2045-2026",
            "Status": "recorded"
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          "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"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-03-16",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Medline Kit SKU DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090;  Medline Kit SKU IVS1975A:  UDI/DI each 10653160327936, UDI/DI case 00653160327939, Lot Number: 2025100890;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2025103190;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2025110590;  Medline Kit SKU DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025110790;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2025111990;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2025112490;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2025120990;  Medline Kit SKU DM100:  UDI/DI each 10653160280101, UDI/DI case 00653160280104, Lot Number: 2026010690;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2026011390;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2026011390;  Medline Kit SKU DT7340:  UDI/DI each 00653160091427, UDI/DI case 50653160091422, Lot Number: 2026021090;  Medline Kit SKU DM660:  UDI/DI each 10653160290667, UDI/DI case 00653160290660, Lot Number: 2026020690;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2026020990;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2026021290;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2026021790;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2025121990;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2026020990.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
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}