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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1503-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT",
  "description": "FDA recall Z-1503-2026 — Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT (Devices, Class III). 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/",
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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-1503-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Penner Patient Care, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1503-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1503-2026: Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT",
      "text": "The FDA logged enforcement record Z-1503-2026: Penner Patient Care, Inc. is voluntarily recalling Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT — reason: The device does not bear a unique device identifier.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-13. Affected lots/codes: UDI-DI: 0085007365404; Serial Numbers: 02216037601 03246681301 11193096501 07216136901 07216138701 02256869801 03246682501 11182940901 11193101101 03226290001 03226290002 01162459901 01203113001 01203113002 01203113003 07203175801 07203175801 01226258801 10226408401 03203144501 11246797902 09226392901 05246713601 03236484701 09203194901 02203122501 02203122502 02203122503 02203122504 02203122601 02203122602 02203122603 02203122604 11226426701 03203142501 03203142502 05203157501 05203157502 05203157503 05203157601 05203157602 05203157603 05203157604 05203157504 10193084101 09226392902 05193018501 08203193401 08203193402 08203193403 07216151601 07216151601 02256888101 01256839901 06236541501 10152425602 06216119401 12182945101 09182915101 08246758501 11182940902 11193101101 10246773801 01203111201 01216046301 02203130401 03192992401 12182948001 05193021901 11216226301 02203136301 01246652801 01203122501 01203122502 01203122503 01203122504 01203122601 01203122602 01203122603 01203122604 10193084001 09182915901 09182915902 09193066701 05236514701 03226301001 12236630301 12236630303 04226315101 10193084002 10182927201 10193082701 12182946801 08193059801 02226274001 01192967301 11193099201 07203179601 01203114201 11246792901 11246790701 11246790703 02226274201 02226274202 02226274203 08236568601 03226289804 06193009601 06193009602 01192956301 09193071501 0919371501 08203190801 08182901101 08182901102 08182901103 04216090901 02236473201 12246806301 06216121801 06216121802 06216121803 06216121804 06216121805 06216121806 10216191301 10182930001 02203137801 07236553801 12216232501 12216232503 01256840201 03236489601 03236489603 05193018701 03192986401 06226336201 11193098201 07216145901 10203210901 05193020101 05193020201 01192967401 01236449801 09193068001 08216157101 05203162001 06203164901 12236631201 09203199501 08203193601 06193031201 01192958901 11182936701 08182900501 08182900502 09193723010 09193723020 06193037201 06226338401 06226338402 05236516301 01246647401 02203131901 10193083101 09226388401 01216015501 04246699001 04246699002 04246699003 06203170401 12182947801 04193006501 08203185601 11216214101 10182930901 12236633401 12236633402 09193068601 12236633601 09182913801 09182913802 02246673601 05182851401 10226412301 05246713201 09182915201 03226287701 12193109801 06236537701 06236537702 06236537703 06236537704 08236571901 08236563101 07216152701 01236452801 05203156601 10203212601 10203212602 10203212603 10203212604 02256869801 03256916201 03256923701 03256923702. 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-1503-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1503-2026&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-1503-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1503-2026 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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": {
        "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-1503-2026&lang=eng",
        "value": "Class III",
        "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-1503-2026&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-1503-2026/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,
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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-1503-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1503-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class III",
            "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": "Penner Patient Care, Inc.",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The device does not bear a unique device identifier.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-08-13",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 0085007365404; Serial Numbers: 02216037601 03246681301 11193096501 07216136901 07216138701 02256869801 03246682501 11182940901 11193101101 03226290001 03226290002 01162459901 01203113001 01203113002 01203113003 07203175801 07203175801 01226258801 10226408401 03203144501 11246797902 09226392901 05246713601 03236484701 09203194901 02203122501 02203122502 02203122503 02203122504 02203122601 02203122602 02203122603 02203122604 11226426701 03203142501 03203142502 05203157501 05203157502 05203157503 05203157601 05203157602 05203157603 05203157604 05203157504 10193084101 09226392902 05193018501 08203193401 08203193402 08203193403 07216151601 07216151601 02256888101 01256839901 06236541501 10152425602 06216119401 12182945101 09182915101 08246758501 11182940902 11193101101 10246773801 01203111201 01216046301 02203130401 03192992401 12182948001 05193021901 11216226301 02203136301 01246652801 01203122501 01203122502 01203122503 01203122504 01203122601 01203122602 01203122603 01203122604 10193084001 09182915901 09182915902 09193066701 05236514701 03226301001 12236630301 12236630303 04226315101 10193084002 10182927201 10193082701 12182946801 08193059801 02226274001 01192967301 11193099201 07203179601 01203114201 11246792901 11246790701 11246790703 02226274201 02226274202 02226274203 08236568601 03226289804 06193009601 06193009602 01192956301 09193071501 0919371501 08203190801 08182901101 08182901102 08182901103 04216090901 02236473201 12246806301 06216121801 06216121802 06216121803 06216121804 06216121805 06216121806 10216191301 10182930001 02203137801 07236553801 12216232501 12216232503 01256840201 03236489601 03236489603 05193018701 03192986401 06226336201 11193098201 07216145901 10203210901 05193020101 05193020201 01192967401 01236449801 09193068001 08216157101 05203162001 06203164901 12236631201 09203199501 08203193601 06193031201 01192958901 11182936701 08182900501 08182900502 09193723010 09193723020 06193037201 06226338401 06226338402 05236516301 01246647401 02203131901 10193083101 09226388401 01216015501 04246699001 04246699002 04246699003 06203170401 12182947801 04193006501 08203185601 11216214101 10182930901 12236633401 12236633402 09193068601 12236633601 09182913801 09182913802 02246673601 05182851401 10226412301 05246713201 09182915201 03226287701 12193109801 06236537701 06236537702 06236537703 06236537704 08236571901 08236563101 07216152701 01236452801 05203156601 10203212601 10203212602 10203212603 10203212604 02256869801 03256916201 03256923701 03256923702",
            "Status": "recorded"
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        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}