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  "name": "Penner Pacific Bathing Spa, Model Numbers 360020-1P",
  "description": "FDA recall Z-1502-2026 — Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 360020-1P (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Penner Pacific Bathing Spa, Model Numbers 360020-1P",
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      "name": "FDA recall Z-1502-2026: Penner Patient Care, Inc. is recalling Penner Pacific Bathing Spa, Model Numbers 360020-1P",
      "text": "The FDA logged enforcement record Z-1502-2026: Penner Patient Care, Inc. is voluntarily recalling Penner Pacific Bathing Spa, Model Numbers 360020-1P — 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: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801. A RECORDED FDA enforcement action (occurred=true).",
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        "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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-1502-2026 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.",
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1502-2026/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.",
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      "epistemicStatus": {
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      "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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