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  "name": "Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230    Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.",
  "description": "FDA recall Z-0058-2025 — Merit Medical Systems, Inc. is recalling Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230    Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid. (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": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230    Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Merit Medical Systems, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0058-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0058-2025: Merit Medical Systems, Inc. is recalling Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230    Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.",
      "text": "The FDA logged enforcement record Z-0058-2025: Merit Medical Systems, Inc. is voluntarily recalling Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230    Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid. — reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-30. Affected lots/codes: Catalog Number: IN2230/B UDI-DI code: 00884450298039 Lot Number: H2287420 H2292343 H2298614 H2305033 H2309342 H2312490 H2320981 H2326309 H2331538 H2337132 H2343845 H2348707 H2353507 H2360151 H2379871 H2385818 H2395792 H2398304 H2413090 H2416387 H2421986 H2432426 H2435878 H2442961 H2446109 H2453675 H2457933 H2458274 H2466447 H2474177 H2478393 H2483314 H2486956 H2492840 H2497955 H2503844 H2507119 H2511930 H2517517 H2522877 H2528486 H2540011 H2545410 H2550516 H2554634 H2560206 H2564557 H2568221 H2574048 H2579553 H2584200 H2589842 H2594940 H2599814 H2604238 H2610524 H2614052 H2618903 H2622808 H2629605 H2633298 H2639295 H2645646 H2649893 H2655505 H2660061 H2664662 H2669779 H2673553 H2675990 H2683251 H2701290 H2709357 H2713928 H2733074 H2739475 H2746858 H2751186 H2760546 H2765638 H2789805 H2819396. A RECORDED FDA enforcement action (occurred=true).",
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        "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0058-2025/fda-classification",
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      "name": "FDA classified recall Z-0058-2025 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "adjudged": true,
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        "value": "Class II",
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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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        "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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      "name": "FDA recall details — Z-0058-2025",
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            "Value": "Z-0058-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Merit Medical Systems, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-08-30",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number: IN2230/B UDI-DI code: 00884450298039 Lot Number: H2287420 H2292343 H2298614 H2305033 H2309342 H2312490 H2320981 H2326309 H2331538 H2337132 H2343845 H2348707 H2353507 H2360151 H2379871 H2385818 H2395792 H2398304 H2413090 H2416387 H2421986 H2432426 H2435878 H2442961 H2446109 H2453675 H2457933 H2458274 H2466447 H2474177 H2478393 H2483314 H2486956 H2492840 H2497955 H2503844 H2507119 H2511930 H2517517 H2522877 H2528486 H2540011 H2545410 H2550516 H2554634 H2560206 H2564557 H2568221 H2574048 H2579553 H2584200 H2589842 H2594940 H2599814 H2604238 H2610524 H2614052 H2618903 H2622808 H2629605 H2633298 H2639295 H2645646 H2649893 H2655505 H2660061 H2664662 H2669779 H2673553 H2675990 H2683251 H2701290 H2709357 H2713928 H2733074 H2739475 H2746858 H2751186 H2760546 H2765638 H2789805 H2819396",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of  Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.",
            "Status": "recorded"
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