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  "name": "Brand Name: HOMEDICS  Product Name: Air Compression Leg Massager  Model/Catalog Number: SR-160HJ  Product Description: Powered Inflatable Tube Massager used on the leg.    The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.",
  "description": "FDA recall Z-2463-2025 — Zhejiang Luyao Electronics Technology Co., Ltd. is recalling Brand Name: HOMEDICS  Product Name: Air Compression Leg Massager  Model/Catalog Number: SR-160HJ  Product Description: Powered Inflatable Tube Massager used on the leg.    The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment. (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": "Brand Name: HOMEDICS  Product Name: Air Compression Leg Massager  Model/Catalog Number: SR-160HJ  Product Description: Powered Inflatable Tube Massager used on the leg.    The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.",
    "manufacturer": {
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      "name": "Zhejiang Luyao Electronics Technology Co., Ltd."
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      "name": "FDA recall Z-2463-2025: Zhejiang Luyao Electronics Technology Co., Ltd. is recalling Brand Name: HOMEDICS  Product Name: Air Compression Leg Massager  Model/Catalog Number: SR-160HJ  Product Description: Powered Inflatable Tube Massager used on the leg.    The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.",
      "text": "The FDA logged enforcement record Z-2463-2025: Zhejiang Luyao Electronics Technology Co., Ltd. is voluntarily recalling Brand Name: HOMEDICS  Product Name: Air Compression Leg Massager  Model/Catalog Number: SR-160HJ  Product Description: Powered Inflatable Tube Massager used on the leg.    The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment. — reason: Regulatory documentation error and misleading color packaging claim.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-17. Affected lots/codes: UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-2463-2025 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.",
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      "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."
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      "@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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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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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            "Field": "Distribution pattern",
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