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  "name": "MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.",
  "description": "FDA recall Z-0033-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. (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": "FDA recall Z-0033-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.",
      "text": "The FDA logged enforcement record Z-0033-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. — reason: It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-30. Affected lots/codes: GTIN 00888277704049. Lot Numbers: L230480007, L230880007, L231080007, L231280007, L240380007. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0033-2025 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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      "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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