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  "name": "Mojo 2 Full Face Non Vented Mask, All Sizes",
  "description": "FDA recall Z-1354-2024 — SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Mask, All Sizes (Devices, Class I). 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-1354-2024: SleepNet Corporation is recalling Mojo 2 Full Face Non Vented Mask, All Sizes",
      "text": "The FDA logged enforcement record Z-1354-2024: SleepNet Corporation is voluntarily recalling Mojo 2 Full Face Non Vented Mask, All Sizes — reason: Update to contraindications and warning language due to CPAP masks containing magnets.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-01. Affected lots/codes: All UDI-DI; All Lot Numbers.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1354-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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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      "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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        "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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