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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2610-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH",
  "description": "FDA recall Z-2610-2025 — Medline Industries, LP is recalling Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH (Devices, Class I). 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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  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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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": {
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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-2610-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2610-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2610-2025: Medline Industries, LP is recalling Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH",
      "text": "The FDA logged enforcement record Z-2610-2025: Medline Industries, LP is voluntarily recalling Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH — reason: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-31. Affected lots/codes: Item Number/UDI (ea)/UDI(case):  401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600RH 10888277407541 20888277407548; 401603RH 10888277407558 20888277407555; 401606RH 10888277407565 20888277407562; 401652RH 10888277407572 20888277407579; 401653RH 10888277407589 20888277407586; 401654RH 10888277407596 20888277407593; 401904RH 10888277407602 20888277407609; 401905RH 10888277407619 20888277407616; 401908RH 10197344020966 20197344020963; 401914RH 10888277407527 20888177407524; 401915RH 10888277407626 20888277407623; 401918RH 10888277407640 20888277407647; 401932RH 10888277407671 20888277407678; 401933RH 10888277407688 20888277407685; 401934RH 10888277407695 20888277407692; 401938RH 10888277407701 20888277407708; 401939RH 10888277407718 20888277407715; 401940RH 10888277407480 20888277407487; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753;  LOTS  EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 EP240212 EP240227 EP240311 EP240322 EP240411 EP240415 EP240422 EP240429 EP240507 EP240514 EP240520 EP240528 EP240607 EP240611 EP240710 EP240715 EP240723 EP240805 EP240812 EP240820 EP240829 EP240911 EP240923 EP240930 EP241008 EP241030 EP241125 EP250108. 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-2610-2025&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-2610-2025&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-2610-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2610-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I",
        "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-2610-2025&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-2610-2025/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
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      "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-2610-2025",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2610-2025",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "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": "Medline Industries, LP",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-07-31",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Item Number/UDI (ea)/UDI(case):  401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600RH 10888277407541 20888277407548; 401603RH 10888277407558 20888277407555; 401606RH 10888277407565 20888277407562; 401652RH 10888277407572 20888277407579; 401653RH 10888277407589 20888277407586; 401654RH 10888277407596 20888277407593; 401904RH 10888277407602 20888277407609; 401905RH 10888277407619 20888277407616; 401908RH 10197344020966 20197344020963; 401914RH 10888277407527 20888177407524; 401915RH 10888277407626 20888277407623; 401918RH 10888277407640 20888277407647; 401932RH 10888277407671 20888277407678; 401933RH 10888277407688 20888277407685; 401934RH 10888277407695 20888277407692; 401938RH 10888277407701 20888277407708; 401939RH 10888277407718 20888277407715; 401940RH 10888277407480 20888277407487; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753;  LOTS  EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 EP240212 EP240227 EP240311 EP240322 EP240411 EP240415 EP240422 EP240429 EP240507 EP240514 EP240520 EP240528 EP240607 EP240611 EP240710 EP240715 EP240723 EP240805 EP240812 EP240820 EP240829 EP240911 EP240923 EP240930 EP241008 EP241030 EP241125 EP250108",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic US distribution nationwide. International distribution pending. No international distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}