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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0112-2026.jsonld",
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  "name": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter",
  "description": "FDA recall Z-0112-2026 — Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter (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": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0112-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0112-2026: Abbott is recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter",
      "text": "The FDA logged enforcement record Z-0112-2026: Abbott is voluntarily recalling TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter — reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-10. Affected lots/codes: GTIN 05415067034618, Batch Numbers:  10093213, 10093588, 10095366, 10096269, 10118676, 10131389, 10151333, 10180969, 10286877, 10315661, 10317649, 10329929, 10332297, 10344177, 10350400, 10360030, 10374171, 10375844, 10418954, 10431765, 10433617, 10450462, 10492093, 10494298, 10537000, 10537747, 10538321, 10557710, 10557878, 10558450, 10559655, 10569703, 10570507, 10571902, 10571907, 10574230, 10575746, 10575752, 10577567, 10578953, 10579724, 10580699, 10581612, 10581681, 10583203, 10583793, 10587033, 10587043, 10587653, 10589068, 10589921, 10591178, 10591238, 10592227, 10606628, 10606720, 10608438, 10608708, 10611469, 10611683, 10612686, 10614973, 10616329, 10618038, 10619154, 10621180, 10622172, 10622962, 10622967, 10625101, 10630682, 10630687, 10632744, 10633145, 10634830, 10636059, 10637023, 10639373, 10639374, 10639376, 10639377, 10641739, 10641741, 10642345, 10643887, 10644681, 10645838, 10646429, 10648576, 10662844, 10665077, 10666137, 10667210, 10667217, 10668065, 10668185, 10670353, 10670360, 10671604, 10671663, 10672934, 10674544, 10675329, 10675541, 10677719, 10677722, 10678784, 10680052, 10680962, 10684449, 10691502, 10691504, 10691507, 10692805, 10696082, 10696083, 10696084, 10705825, 10708749, 10708800, 10709735, 10711022, 10711803, 10712639, 10712641, 10714607, 10714611, 10715850, 10717049, 10717050, 10719520, 10721238, 10721239, 10725441, 10725442, 10747196, 10749817, 10749820, 10749823, 10751484, 10762186, 10762464, 10764517, 10764523, 10765657, 10766897, 10767820, 10769643, 10770889, 10772623, 10772625, 10773775, 10773811, 10776251, 10777548, 10778157, 10779451, 10808389, 10808390, 10808393, 10811066, 10811067, 10811262, 10821034, 10827717, 10829276, 10829990, 10830744, 10832015, 10832019, 10832727, 10834411, 10834412, 10835187, 10836468, 10836482, 10836911, 10837558, 10837559, 10839959, 10839960, 10841679, 10841690, 10842962, 10845198, 10845199, 10846600, 10847688, 10847695, 10850757, 10850761, 10856004, 10856065, 10858260, 10867490, 10867495, 10868706, 10873737, 10873924, 10875772, 10875773, 10877194, 10897765, 10899500, 10899504, 10902557, 10902569, 10905178, 10905907, 10906368, 10907259, 10909995, 10910050, 10911332, 10911333, 10913977, 10915227, 10915230, 10920111, 10922315, 10922528, 10924643, 10924802, 10927218, 10954504, 10954507, 10955716, 10956520, 10956521, 10958150, 10959364, 10959373, 10960184, 10962699, 10965714, 10970014, 10970054, 10985513, 10989401, 10990017, 10990759, 10992074, 10992078, 10987781.. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0112-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0112-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0112-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0112-2026/boundary",
      "@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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Distribution pattern",
            "Value": "Worldwide",
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