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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0230-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "LIFEPAK 15 (LP15) Model/Catalog Numbers:  o 97577-000101  o 99577-000046  o 99577-000055  o 99577-000061  o 99577-000076  o 99577-001250  o 99577-001255  o 99577-001256  o 99577-001368  o 99577-001955  o 99577-001956  o 99577-001957  o 99577-001958  o 99577-001962  LIFEPAK 15 intended use monitor/defibrillator.",
  "description": "FDA recall Z-0230-2025 — Physio-Control, Inc. is recalling LIFEPAK 15 (LP15) Model/Catalog Numbers:  o 97577-000101  o 99577-000046  o 99577-000055  o 99577-000061  o 99577-000076  o 99577-001250  o 99577-001255  o 99577-001256  o 99577-001368  o 99577-001955  o 99577-001956  o 99577-001957  o 99577-001958  o 99577-001962  LIFEPAK 15 intended use monitor/defibrillator. (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": {
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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-0230-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "LIFEPAK 15 (LP15) Model/Catalog Numbers:  o 97577-000101  o 99577-000046  o 99577-000055  o 99577-000061  o 99577-000076  o 99577-001250  o 99577-001255  o 99577-001256  o 99577-001368  o 99577-001955  o 99577-001956  o 99577-001957  o 99577-001958  o 99577-001962  LIFEPAK 15 intended use monitor/defibrillator.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Physio-Control, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0230-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0230-2025: Physio-Control, Inc. is recalling LIFEPAK 15 (LP15) Model/Catalog Numbers:  o 97577-000101  o 99577-000046  o 99577-000055  o 99577-000061  o 99577-000076  o 99577-001250  o 99577-001255  o 99577-001256  o 99577-001368  o 99577-001955  o 99577-001956  o 99577-001957  o 99577-001958  o 99577-001962  LIFEPAK 15 intended use monitor/defibrillator.",
      "text": "The FDA logged enforcement record Z-0230-2025: Physio-Control, Inc. is voluntarily recalling LIFEPAK 15 (LP15) Model/Catalog Numbers:  o 97577-000101  o 99577-000046  o 99577-000055  o 99577-000061  o 99577-000076  o 99577-001250  o 99577-001255  o 99577-001256  o 99577-001368  o 99577-001955  o 99577-001956  o 99577-001957  o 99577-001958  o 99577-001962  LIFEPAK 15 intended use monitor/defibrillator. — reason: Due to an out of tolerance tool being used on monitor/defibrillator systems.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-30. Affected lots/codes: LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962  UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645  Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "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-0230-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0230-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0230-2025 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-0230-2025&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-0230-2025/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.",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "groundingType": "Interpretation",
        "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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            "Value": "Z-0230-2025",
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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",
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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": "Physio-Control, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to an out of tolerance tool being used on monitor/defibrillator systems.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-30",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962  UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645  Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: CT, GA, MA, NY, OH, WA, and WV.  O.U.S.: N/A",
            "Status": "recorded"
          }
        }
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}