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  "name": "Brand Name: NOVA ORTHO-MED INC.  Product Name: MONARCH ROLLATOR PURPLE  Model/Catalog Number: 4329PL  Product Description: ROLLING WALKER MOBILITY AID",
  "description": "FDA recall Z-0130-2025 — Nova Ortho-Med Inc is recalling Brand Name: NOVA ORTHO-MED INC.  Product Name: MONARCH ROLLATOR PURPLE  Model/Catalog Number: 4329PL  Product Description: ROLLING WALKER MOBILITY AID (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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      "name": "FDA recall Z-0130-2025: Nova Ortho-Med Inc is recalling Brand Name: NOVA ORTHO-MED INC.  Product Name: MONARCH ROLLATOR PURPLE  Model/Catalog Number: 4329PL  Product Description: ROLLING WALKER MOBILITY AID",
      "text": "The FDA logged enforcement record Z-0130-2025: Nova Ortho-Med Inc is voluntarily recalling Brand Name: NOVA ORTHO-MED INC.  Product Name: MONARCH ROLLATOR PURPLE  Model/Catalog Number: 4329PL  Product Description: ROLLING WALKER MOBILITY AID — reason: Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-26. Affected lots/codes: Lot Code: ITEM CODE: 4329PL SN RANGE: HT4329PLME0001 - HT4329PLMM0400 UPC: 652308012256. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0130-2025 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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      "@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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      "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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