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  "name": "Approach Hydro ST Micro Wire Guide; Catalog prefix HMW    Reference Part Numbers:  HMW-14-135-ST  HMW-14-190-ST  HMW-14-300-ST",
  "description": "FDA recall Z-0347-2025 — Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide; Catalog prefix HMW    Reference Part Numbers:  HMW-14-135-ST  HMW-14-190-ST  HMW-14-300-ST (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": "Approach Hydro ST Micro Wire Guide; Catalog prefix HMW    Reference Part Numbers:  HMW-14-135-ST  HMW-14-190-ST  HMW-14-300-ST",
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      "name": "FDA recall Z-0347-2025: Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide; Catalog prefix HMW    Reference Part Numbers:  HMW-14-135-ST  HMW-14-190-ST  HMW-14-300-ST",
      "text": "The FDA logged enforcement record Z-0347-2025: Cook Incorporated is voluntarily recalling Approach Hydro ST Micro Wire Guide; Catalog prefix HMW    Reference Part Numbers:  HMW-14-135-ST  HMW-14-190-ST  HMW-14-300-ST — reason: Affected device lots have labels that state the incorrect expiration dates.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-08. Affected lots/codes: RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 15971771 15974437 16012937 15971771X 16012937X   HMW-14-190-ST/ 00827002529380/ 15726043 15726044 15765947 15765955 15778260 15800165 15800166 15811656 15811657 15821245 15829376 15831156 15835857 15849644 15858389 15874633 15885580 15891903 15894221 15894222 15907469 15908739 15943873 15943874 15943881 15943882 15945799 15945801 15952502 15971778 15971779 15979320 15988603 15999088 15999089 16018914 16018917 16018919 15874633X 16018919X NS15765956 NS15769470 NS15783001 NS15794893 NS15802918 NS15821246 NS15835858 NS15849643 NS15915900 NS16029493  HMW-14-300-ST/ 00827002529397/  15718978 15718979 15720963 15726042 15726045 15731209 15731210 15735502 15765946 15765948 15765949 15765950 15765951 15765952 15765953 15769463 15769464 15769465 15769466 15769467 15769469 15778257 15778258 15778259 15794890 15794891 15800167 15802919 15802920 15802921 15811658 15816909 15816910 15821248 15821250 15829375 15829377 15831157 15831159 15843561 15845744 15845745 15845746 15858390 15858391 15858392 15863266 15863267 15863268 15879455 15885581 15885582 15885583 15885584 15891901 15891902 15892394 15894223 15894224 15894225 15894226 15894227 15898542 15902068 15902069 15902070 15925109 15925110 15925111 15925113 15925114 15943875 15943876 15943877 15943878 15943879 15943880 15943883 15943884 15943885 15945800 15952500 15952501 15958703 15971772 15971773 15971774 15971775 15971776 15971777 15971780 15979321 15988604 15995198 15995199 15995200 16004716 16004717 16004718 16004719 16004720 16004721 16010288 16010289 16018915 16018918 16025193 16029492 16042142 16042143 16042144 16042145 15726042X 15843560X 15902070X 15943885X NS15720964 NS15766147 NS15769468 NS15794892 NS15800168 NS15802922 NS15821247 NS15821249 NS15845747 NS15856480 NS15858393 NS15892395 NS16018395. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0347-2025 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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      "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",
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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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      "name": "FDA recall details — Z-0347-2025",
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            "Value": "Affected device lots have labels that state the incorrect expiration dates.",
            "Status": "recorded"
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            "Value": "RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 15971771 15974437 16012937 15971771X 16012937X   HMW-14-190-ST/ 00827002529380/ 15726043 15726044 15765947 15765955 15778260 15800165 15800166 15811656 15811657 15821245 15829376 15831156 15835857 15849644 15858389 15874633 15885580 15891903 15894221 15894222 15907469 15908739 15943873 15943874 15943881 15943882 15945799 15945801 15952502 15971778 15971779 15979320 15988603 15999088 15999089 16018914 16018917 16018919 15874633X 16018919X NS15765956 NS15769470 NS15783001 NS15794893 NS15802918 NS15821246 NS15835858 NS15849643 NS15915900 NS16029493  HMW-14-300-ST/ 00827002529397/  15718978 15718979 15720963 15726042 15726045 15731209 15731210 15735502 15765946 15765948 15765949 15765950 15765951 15765952 15765953 15769463 15769464 15769465 15769466 15769467 15769469 15778257 15778258 15778259 15794890 15794891 15800167 15802919 15802920 15802921 15811658 15816909 15816910 15821248 15821250 15829375 15829377 15831157 15831159 15843561 15845744 15845745 15845746 15858390 15858391 15858392 15863266 15863267 15863268 15879455 15885581 15885582 15885583 15885584 15891901 15891902 15892394 15894223 15894224 15894225 15894226 15894227 15898542 15902068 15902069 15902070 15925109 15925110 15925111 15925113 15925114 15943875 15943876 15943877 15943878 15943879 15943880 15943883 15943884 15943885 15945800 15952500 15952501 15958703 15971772 15971773 15971774 15971775 15971776 15971777 15971780 15979321 15988604 15995198 15995199 15995200 16004716 16004717 16004718 16004719 16004720 16004721 16010288 16010289 16018915 16018918 16025193 16029492 16042142 16042143 16042144 16042145 15726042X 15843560X 15902070X 15943885X NS15720964 NS15766147 NS15769468 NS15794892 NS15800168 NS15802922 NS15821247 NS15821249 NS15845747 NS15856480 NS15858393 NS15892395 NS16018395",
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