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  "name": "Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers:    1) ) Product Code/Part # 67MXTP-B-ECG3A;   2) ) Product Code/Part # 67MXTX-B;   3) ) Product Code/Part # 67MXXP-B;   4) ) Product Code/Part # 67MXXX-B;   5) ) Product Code/Part # 67NCTP-B;   6) ) Product Code/Part # 67NCTP-B-ECG3A;   7) ) Product Code/Part # 67NCTX-B;   8) ) Product Code/Part # 67NXEX-B;   9) ) Product Code/Part # 67NXTP-B;   10) ) Product Code/Part # 67NXTP-B-ECG3A;   11) ) Product Code/Part # 67NXTX-B;   12) ) Product Code/Part # 67NXXX-B;   13) ) Product Code/Part # 68MCTP-B;   14) ) Product Code/Part # 68MCTP-B-ECG3A;   15) ) Product Code/Part # 68MCTX-B;   16) ) Product Code/Part # 68MCXX-B;   17) ) Product Code/Part # 68MXDX-B;   18) ) Product Code/Part # 68MXEP-B;   19) ) Product Code/Part # 68MXEX-B;   20) ) Product Code/Part # 68MXTP-B;   21) ) Product Code/Part # 68MXTP-B-ECG3A;   22) ) Product Code/Part # 68MXTX-B;   23) ) Product Code/Part # 68MXTX-BR;   24) ) Product Code/Part # 68NCEP-B;   25) ) Product Code/Part # 68NCTP-B;   26) ) Product Code/Part # 68NCTP-B-ECG3A;   27) ) Product Code/Part # 68NCTX-B;   28) ) Product Code/Part # 68NCXP-B;   29) ) Product Code/Part # 68NXEP-B;   30) ) Product Code/Part # 68NXEX-B;   31) ) Product Code/Part # 68NXTP-B;   32) ) Product Code/Part # 68NXTP-B-ECG3A;   33) ) Product Code/Part # 68NXTX-B;   34) ) Product Code/Part # 68NXTX-BR;   35) ) Product Code/Part # 68NXXX-B;   36) ) Product Code/Part # 67MCTP-B;   37) ) Product Code/Part # 67MCTP-B-ECG3A;   38) ) Product Code/Part # 67MCTX-B;   39) ) Product Code/Part # 67MXEX-B;   40) ) Product Code/Part # 67MXTP-B;   41) ) Product Code/Part # 68MXXX-B.",
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      "name": "FDA recall Z-1564-2025: Baxter Healthcare Corporation is recalling Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers:    1) ) Product Code/Part # 67MXTP-B-ECG3A;   2) ) Product Code/Part # 67MXTX-B;   3) ) Product Code/Part # 67MXXP-B;   4) ) Product Code/Part # 67MXXX-B;   5) ) Product Code/Part # 67NCTP-B;   6) ) Product Code/Part # 67NCTP-B-ECG3A;   7) ) Product Code/Part # 67NCTX-B;   8) ) Product Code/Part # 67NXEX-B;   9) ) Product Code/Part # 67NXTP-B;   10) ) Product Code/Part # 67NXTP-B-ECG3A;   11) ) Product Code/Part # 67NXTX-B;   12) ) Product Code/Part # 67NXXX-B;   13) ) Product Code/Part # 68MCTP-B;   14) ) Product Code/Part # 68MCTP-B-ECG3A;   15) ) Product Code/Part # 68MCTX-B;   16) ) Product Code/Part # 68MCXX-B;   17) ) Product Code/Part # 68MXDX-B;   18) ) Product Code/Part # 68MXEP-B;   19) ) Product Code/Part # 68MXEX-B;   20) ) Product Code/Part # 68MXTP-B;   21) ) Product Code/Part # 68MXTP-B-ECG3A;   22) ) Product Code/Part # 68MXTX-B;   23) ) Product Code/Part # 68MXTX-BR;   24) ) Product Code/Part # 68NCEP-B;   25) ) Product Code/Part # 68NCTP-B;   26) ) Product Code/Part # 68NCTP-B-ECG3A;   27) ) Product Code/Part # 68NCTX-B;   28) ) Product Code/Part # 68NCXP-B;   29) ) Product Code/Part # 68NXEP-B;   30) ) Product Code/Part # 68NXEX-B;   31) ) Product Code/Part # 68NXTP-B;   32) ) Product Code/Part # 68NXTP-B-ECG3A;   33) ) Product Code/Part # 68NXTX-B;   34) ) Product Code/Part # 68NXTX-BR;   35) ) Product Code/Part # 68NXXX-B;   36) ) Product Code/Part # 67MCTP-B;   37) ) Product Code/Part # 67MCTP-B-ECG3A;   38) ) Product Code/Part # 67MCTX-B;   39) ) Product Code/Part # 67MXEX-B;   40) ) Product Code/Part # 67MXTP-B;   41) ) Product Code/Part # 68MXXX-B.",
      "text": "The FDA logged enforcement record Z-1564-2025: Baxter Healthcare Corporation is voluntarily recalling Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers:    1) ) Product Code/Part # 67MXTP-B-ECG3A;   2) ) Product Code/Part # 67MXTX-B;   3) ) Product Code/Part # 67MXXP-B;   4) ) Product Code/Part # 67MXXX-B;   5) ) Product Code/Part # 67NCTP-B;   6) ) Product Code/Part # 67NCTP-B-ECG3A;   7) ) Product Code/Part # 67NCTX-B;   8) ) Product Code/Part # 67NXEX-B;   9) ) Product Code/Part # 67NXTP-B;   10) ) Product Code/Part # 67NXTP-B-ECG3A;   11) ) Product Code/Part # 67NXTX-B;   12) ) Product Code/Part # 67NXXX-B;   13) ) Product Code/Part # 68MCTP-B;   14) ) Product Code/Part # 68MCTP-B-ECG3A;   15) ) Product Code/Part # 68MCTX-B;   16) ) Product Code/Part # 68MCXX-B;   17) ) Product Code/Part # 68MXDX-B;   18) ) Product Code/Part # 68MXEP-B;   19) ) Product Code/Part # 68MXEX-B;   20) ) Product Code/Part # 68MXTP-B;   21) ) Product Code/Part # 68MXTP-B-ECG3A;   22) ) Product Code/Part # 68MXTX-B;   23) ) Product Code/Part # 68MXTX-BR;   24) ) Product Code/Part # 68NCEP-B;   25) ) Product Code/Part # 68NCTP-B;   26) ) Product Code/Part # 68NCTP-B-ECG3A;   27) ) Product Code/Part # 68NCTX-B;   28) ) Product Code/Part # 68NCXP-B;   29) ) Product Code/Part # 68NXEP-B;   30) ) Product Code/Part # 68NXEX-B;   31) ) Product Code/Part # 68NXTP-B;   32) ) Product Code/Part # 68NXTP-B-ECG3A;   33) ) Product Code/Part # 68NXTX-B;   34) ) Product Code/Part # 68NXTX-BR;   35) ) Product Code/Part # 68NXXX-B;   36) ) Product Code/Part # 67MCTP-B;   37) ) Product Code/Part # 67MCTP-B-ECG3A;   38) ) Product Code/Part # 67MCTX-B;   39) ) Product Code/Part # 67MXEX-B;   40) ) Product Code/Part # 67MXTP-B;   41) ) Product Code/Part # 68MXXX-B. — reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-21. Affected lots/codes: 1) Product Code/Part # 67MXTP-B-ECG3A, UDI/DI 00732094323788;  2) Product Code/Part # 67MXTX-B, UDI/DI 00732094151244;  3) Product Code/Part # 67MXXP-B, UDI/DI 00732094151237;  4) Product Code/Part # 67MXXX-B, UDI/DI 00732094151220;  5) Product Code/Part # 67NCTP-B, UDI/DI 00732094151190;  6) Product Code/Part # 67NCTP-B-ECG3A, UDI/DI 00732094323771;  7) Product Code/Part # 67NCTX-B, UDI/DI 00732094151183;  8) Product Code/Part # 67NXEX-B, UDI/DI 00732094151145;  9) Product Code/Part # 67NXTP-B, UDI/DI 00732094151138;  10) Product Code/Part # 67NXTP-B-ECG3A, UDI/DI 00732094323764;  11) Product Code/Part # 67NXTX-B, UDI/DI 00732094151121;  12) Product Code/Part # 67NXXX-B, UDI/DI 00732094151107;  13) Product Code/Part # 68MCTP-B, UDI/DI 00732094151060;  14) Product Code/Part # 68MCTP-B-ECG3A, UDI/DI 00732094345919;  15) Product Code/Part # 68MCTX-B, UDI/DI 00732094151053;  16) Product Code/Part # 68MCXX-B, UDI/DI 00732094151039;  17) Product Code/Part # 68MXDX-B, UDI/DI 00732094249187;  18) Product Code/Part # 68MXEP-B, UDI/DI 00732094150964;  19) Product Code/Part # 68MXEX-B, UDI/DI 00732094150957;  20) Product Code/Part # 68MXTP-B, UDI/DI 00732094150940;  21) Product Code/Part # 68MXTP-B-ECG3A, UDI/DI 00732094345902;  22) Product Code/Part # 68MXTX-B, UDI/DI 00732094150933;  23) Product Code/Part # 68MXTX-BR, UDI/DI 00732094322613;  24) Product Code/Part # 68NCEP-B, UDI/DI 00732094150902;  25) Product Code/Part # 68NCTP-B, UDI/DI 00732094150889;  26) Product Code/Part # 68NCTP-B-ECG3A, UDI/DI 00732094345896;  27) Product Code/Part # 68NCTX-B, UDI/DI 00732094150872;  28) Product Code/Part # 68NCXP-B, UDI/DI 00732094150865;  29) Product Code/Part # 68NXEP-B, UDI/DI 00732094150841;  30) Product Code/Part # 68NXEX-B, UDI/DI 00732094150834;  31) Product Code/Part # 68NXTP-B, UDI/DI 00732094150827;  32) Product Code/Part # 68NXTP-B-ECG3A, UDI/DI 00732094345889;  33) Product Code/Part # 68NXTX-B, UDI/DI 00732094150810;  34) Product Code/Part # 68NXTX-BR, UDI/DI 00732094322590;  35) Product Code/Part # 68NXXX-B, UDI/DI 00732094150797;  36) Product Code/Part # 67MCTP-B, UDI/DI 00732094151374;  37) Product Code/Part # 67MCTP-B-ECG3A, UDI/DI 00732094323795;  38) Product Code/Part # 67MCTX-B, UDI/DI 00732094151367;  39) Product Code/Part # 67MXEX-B, UDI/DI 00732094151268;  40) Product Code/Part # 67MXTP-B, UDI/DI 00732094151251;  41) Product Code/Part # 68MXXX-B, UDI/DI 00732094150919;  Lot Number 24-314 & lower. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1564-2025 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
      },
      "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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          "item": {
            "Field": "Lot/code info",
            "Value": "1) Product Code/Part # 67MXTP-B-ECG3A, UDI/DI 00732094323788;  2) Product Code/Part # 67MXTX-B, UDI/DI 00732094151244;  3) Product Code/Part # 67MXXP-B, UDI/DI 00732094151237;  4) Product Code/Part # 67MXXX-B, UDI/DI 00732094151220;  5) Product Code/Part # 67NCTP-B, UDI/DI 00732094151190;  6) Product Code/Part # 67NCTP-B-ECG3A, UDI/DI 00732094323771;  7) Product Code/Part # 67NCTX-B, UDI/DI 00732094151183;  8) Product Code/Part # 67NXEX-B, UDI/DI 00732094151145;  9) Product Code/Part # 67NXTP-B, UDI/DI 00732094151138;  10) Product Code/Part # 67NXTP-B-ECG3A, UDI/DI 00732094323764;  11) Product Code/Part # 67NXTX-B, UDI/DI 00732094151121;  12) Product Code/Part # 67NXXX-B, UDI/DI 00732094151107;  13) Product Code/Part # 68MCTP-B, UDI/DI 00732094151060;  14) Product Code/Part # 68MCTP-B-ECG3A, UDI/DI 00732094345919;  15) Product Code/Part # 68MCTX-B, UDI/DI 00732094151053;  16) Product Code/Part # 68MCXX-B, UDI/DI 00732094151039;  17) Product Code/Part # 68MXDX-B, UDI/DI 00732094249187;  18) Product Code/Part # 68MXEP-B, UDI/DI 00732094150964;  19) Product Code/Part # 68MXEX-B, UDI/DI 00732094150957;  20) Product Code/Part # 68MXTP-B, UDI/DI 00732094150940;  21) Product Code/Part # 68MXTP-B-ECG3A, UDI/DI 00732094345902;  22) Product Code/Part # 68MXTX-B, UDI/DI 00732094150933;  23) Product Code/Part # 68MXTX-BR, UDI/DI 00732094322613;  24) Product Code/Part # 68NCEP-B, UDI/DI 00732094150902;  25) Product Code/Part # 68NCTP-B, UDI/DI 00732094150889;  26) Product Code/Part # 68NCTP-B-ECG3A, UDI/DI 00732094345896;  27) Product Code/Part # 68NCTX-B, UDI/DI 00732094150872;  28) Product Code/Part # 68NCXP-B, UDI/DI 00732094150865;  29) Product Code/Part # 68NXEP-B, UDI/DI 00732094150841;  30) Product Code/Part # 68NXEX-B, UDI/DI 00732094150834;  31) Product Code/Part # 68NXTP-B, UDI/DI 00732094150827;  32) Product Code/Part # 68NXTP-B-ECG3A, UDI/DI 00732094345889;  33) Product Code/Part # 68NXTX-B, UDI/DI 00732094150810;  34) Product Code/Part # 68NXTX-BR, UDI/DI 00732094322590;  35) Product Code/Part # 68NXXX-B, UDI/DI 00732094150797;  36) Product Code/Part # 67MCTP-B, UDI/DI 00732094151374;  37) Product Code/Part # 67MCTP-B-ECG3A, UDI/DI 00732094323795;  38) Product Code/Part # 67MCTX-B, UDI/DI 00732094151367;  39) Product Code/Part # 67MXEX-B, UDI/DI 00732094151268;  40) Product Code/Part # 67MXTP-B, UDI/DI 00732094151251;  41) Product Code/Part # 68MXXX-B, UDI/DI 00732094150919;  Lot Number 24-314 & lower",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}