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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1504-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,  361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X",
  "description": "FDA recall Z-1504-2026 — Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,  361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X (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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  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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": {
      "@type": "schema:GovernmentOrganization",
      "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-1504-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,  361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Penner Patient Care, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1504-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1504-2026: Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,  361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X",
      "text": "The FDA logged enforcement record Z-1504-2026: Penner Patient Care, Inc. is voluntarily recalling Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I,  361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X — 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: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301 04246699302 06226346001 03192988001 05193026301 08182896501 08182896502 08182896503 08182896504 05216110201 06246732101 06246732102 05193020401 11216226901 09246768801 11203215901 09182915601 04193013701 01203113401 10246774001 09193066801 07226353001 07226359101 01256834801 08236567401 11236611101 11226430001 02246665701 10182930801 03246680001 01192960601 03236486401 06236533901 05236526702 09216179201 10193089801 06236532901 06236532902 06236532903 08182902101 03192995801 03192995802 09193067401 07205595301 04216084401 04193002001 04193002002 11216213101 11182939701 09193074901 09193074902 01236449501 01236449502 03192987401 03203142901 03203142902 02192981501 02192981502 05226324701 03226296101 09203198701 04246693301 07226356501 04216092701 04236503401 11236613601 11236613602 02226270303 04226309007 04226309008 01246648301 01246648302 06081036001 03203140001 03203140002 03205525101 07226356201 03216055401 04193000001 11203216801 11203216802 07193044101 01203116101 01203116102 01203116103 05246713401 05246713402 07246738901 07193050501 10246777701 12226443001 11226427301 05216098101 11226433501 09226401501 08216173101 08216173102 05203162501 06226339001 06226339002 05193018601 04216081201 11182933201 11182933202 11236611301 09236584601 09236584602 07193042101 12182947701 01256823701 10226421501 01256838101 04216081901 10226417301 09193071201 02246672301 07205596301 12236524501 11193098801 03216073501 01256852601 10246788401 02226266601 03192998901 12182946201 10236598101 05193023401 05193023402 01226261601 02203131401 03192987901 03192987902 03192987903 02246671801 04246704401 06203167601 07246745601 07216151101 10195414701 01236457001 06193029401 06193029402 04256970101. 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-1504-2026&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-1504-2026&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-1504-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1504-2026 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-1504-2026&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-1504-2026&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-1504-2026/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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1504-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1504-2026",
            "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 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"
          }
        },
        {
          "@type": "schema:ListItem",
          "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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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301 04246699302 06226346001 03192988001 05193026301 08182896501 08182896502 08182896503 08182896504 05216110201 06246732101 06246732102 05193020401 11216226901 09246768801 11203215901 09182915601 04193013701 01203113401 10246774001 09193066801 07226353001 07226359101 01256834801 08236567401 11236611101 11226430001 02246665701 10182930801 03246680001 01192960601 03236486401 06236533901 05236526702 09216179201 10193089801 06236532901 06236532902 06236532903 08182902101 03192995801 03192995802 09193067401 07205595301 04216084401 04193002001 04193002002 11216213101 11182939701 09193074901 09193074902 01236449501 01236449502 03192987401 03203142901 03203142902 02192981501 02192981502 05226324701 03226296101 09203198701 04246693301 07226356501 04216092701 04236503401 11236613601 11236613602 02226270303 04226309007 04226309008 01246648301 01246648302 06081036001 03203140001 03203140002 03205525101 07226356201 03216055401 04193000001 11203216801 11203216802 07193044101 01203116101 01203116102 01203116103 05246713401 05246713402 07246738901 07193050501 10246777701 12226443001 11226427301 05216098101 11226433501 09226401501 08216173101 08216173102 05203162501 06226339001 06226339002 05193018601 04216081201 11182933201 11182933202 11236611301 09236584601 09236584602 07193042101 12182947701 01256823701 10226421501 01256838101 04216081901 10226417301 09193071201 02246672301 07205596301 12236524501 11193098801 03216073501 01256852601 10246788401 02226266601 03192998901 12182946201 10236598101 05193023401 05193023402 01226261601 02203131401 03192987901 03192987902 03192987903 02246671801 04246704401 06203167601 07246745601 07216151101 10195414701 01236457001 06193029401 06193029402 04256970101",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}