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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2161-2026.jsonld",
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  "name": "LUCAS 2  Model Number: 99576  Catalog Numbers: 99576-000024 and 99576-000011  UDI-DI code: 00883873904565    LUCAS 3  Model Number: 99576  Catalog Number: 99576-000043  UDI-DI code: 00883873861875    LUCAS 3.1  Model Number: 99576  Catalog Number: 99576-000063  UDI-DI code:  00883873834329    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.",
  "description": "FDA recall Z-2161-2026 — Jolife AB is recalling LUCAS 2  Model Number: 99576  Catalog Numbers: 99576-000024 and 99576-000011  UDI-DI code: 00883873904565    LUCAS 3  Model Number: 99576  Catalog Number: 99576-000043  UDI-DI code: 00883873861875    LUCAS 3.1  Model Number: 99576  Catalog Number: 99576-000063  UDI-DI code:  00883873834329    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2161-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "LUCAS 2  Model Number: 99576  Catalog Numbers: 99576-000024 and 99576-000011  UDI-DI code: 00883873904565    LUCAS 3  Model Number: 99576  Catalog Number: 99576-000043  UDI-DI code: 00883873861875    LUCAS 3.1  Model Number: 99576  Catalog Number: 99576-000063  UDI-DI code:  00883873834329    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Jolife AB"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2161-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2161-2026: Jolife AB is recalling LUCAS 2  Model Number: 99576  Catalog Numbers: 99576-000024 and 99576-000011  UDI-DI code: 00883873904565    LUCAS 3  Model Number: 99576  Catalog Number: 99576-000043  UDI-DI code: 00883873861875    LUCAS 3.1  Model Number: 99576  Catalog Number: 99576-000063  UDI-DI code:  00883873834329    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.",
      "text": "The FDA logged enforcement record Z-2161-2026: Jolife AB is voluntarily recalling LUCAS 2  Model Number: 99576  Catalog Numbers: 99576-000024 and 99576-000011  UDI-DI code: 00883873904565    LUCAS 3  Model Number: 99576  Catalog Number: 99576-000043  UDI-DI code: 00883873861875    LUCAS 3.1  Model Number: 99576  Catalog Number: 99576-000063  UDI-DI code:  00883873834329    LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. — reason: Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-13. Affected lots/codes: LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 Serial Numbers: 30100846 30112125 30123845 30124348 30124440 30124475 30124991 30136605 30148155 30148365 3015B568 3015B682 3015C276 3015C722 3015C723 3015C724 3015F246 3015F587 3016G845 3016H983 3017K078 3017K079 3017K080  LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 Serial Numbers: 35160778 35173272 35173461 35185820 35185817 35175040 35175039 35173347 35160921 35175373 35174279 35172701 35161449  LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code:  00883873834329 Serial Numbers: 3520R763 3522AN95 3519F615 3520N419 3522DK48 3521S574 3521T901 3520R187 3518B300 3522EG06 3520P749 3520R206 3520S005 3520P512 3520P691 3520P741 3520P742 3520P744 3520P745 3520P746 3520P748 3520P810 3520S006 3520P747 3520S003 3521AF21 3518B131 3520L408 3519E743 3521AC18 3521U379 3520O364 3520S292 3519F035 3520S149 3521Z495 3521Z496 3520P082 3520L957 3520R180 3519G235 3519G633 3519H568 3519E607 3522BI32 3518D028 3522CN47 3520K867 3519I425 3520K923 3523FA45 3520O771 3520R123 3521W020 3520K966 3522AV78 3521T568 3520O776 3518A707 3521T325 3521T329 3518C485 3518D396 3522BU41 3519G180 3522AR04 3522AR05 3520R135 3522CR96 3523EN71 3520R209 3520L915 3520L916 3520N979 3520O026 3520O298 3520P109 3520P559 3520S287 3521V691 3522AR01 3522AR03 3518D017 3519E728 3520N729 3519F039 3520L676 3520N364 3520N366 3521S486 3520P539 3521V200 3522BZ70 3523FL02 3523FL03 3521T704 3521T575 3520O549 3520P906 3520P928 3520P930 3522AR07 3520R138 3523EN74 3521V688 3519F034 3523FA47 3520P907 3520S285 3521S487 3522AR00 3522AR06 3523FD33 3519F038 3523FH21 3520N010 3520N505. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
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        "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-2161-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-2161-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2161-2026 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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-2161-2026&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-2161-2026&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-2161-2026/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,
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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."
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      "name": "FDA recall details — Z-2161-2026",
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            "Value": "Z-2161-2026",
            "Status": "recorded"
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          "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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Jolife AB",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).",
            "Status": "recorded"
          }
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2026-04-13",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 Serial Numbers: 30100846 30112125 30123845 30124348 30124440 30124475 30124991 30136605 30148155 30148365 3015B568 3015B682 3015C276 3015C722 3015C723 3015C724 3015F246 3015F587 3016G845 3016H983 3017K078 3017K079 3017K080  LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 Serial Numbers: 35160778 35173272 35173461 35185820 35185817 35175040 35175039 35173347 35160921 35175373 35174279 35172701 35161449  LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code:  00883873834329 Serial Numbers: 3520R763 3522AN95 3519F615 3520N419 3522DK48 3521S574 3521T901 3520R187 3518B300 3522EG06 3520P749 3520R206 3520S005 3520P512 3520P691 3520P741 3520P742 3520P744 3520P745 3520P746 3520P748 3520P810 3520S006 3520P747 3520S003 3521AF21 3518B131 3520L408 3519E743 3521AC18 3521U379 3520O364 3520S292 3519F035 3520S149 3521Z495 3521Z496 3520P082 3520L957 3520R180 3519G235 3519G633 3519H568 3519E607 3522BI32 3518D028 3522CN47 3520K867 3519I425 3520K923 3523FA45 3520O771 3520R123 3521W020 3520K966 3522AV78 3521T568 3520O776 3518A707 3521T325 3521T329 3518C485 3518D396 3522BU41 3519G180 3522AR04 3522AR05 3520R135 3522CR96 3523EN71 3520R209 3520L915 3520L916 3520N979 3520O026 3520O298 3520P109 3520P559 3520S287 3521V691 3522AR01 3522AR03 3518D017 3519E728 3520N729 3519F039 3520L676 3520N364 3520N366 3521S486 3520P539 3521V200 3522BZ70 3523FL02 3523FL03 3521T704 3521T575 3520O549 3520P906 3520P928 3520P930 3522AR07 3520R138 3523EN74 3521V688 3519F034 3523FA47 3520P907 3520S285 3521S487 3522AR00 3522AR06 3523FD33 3519F038 3523FH21 3520N010 3520N505",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of AL, AZ, CA, FL, HI, IA, KS, KY, LA, MA, MD, MN, NC, NV, OH, SC, TX, UT, VA, WA, and WY.",
            "Status": "recorded"
          }
        }
      ]
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}