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  "name": "Monarch Inflation Device  30 atm/bar REF IN2130    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-0057-2025 — Merit Medical Systems, Inc. is recalling Monarch Inflation Device  30 atm/bar REF IN2130    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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Monarch Inflation Device  30 atm/bar REF IN2130    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": {
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      "name": "Merit Medical Systems, Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0057-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0057-2025: Merit Medical Systems, Inc. is recalling Monarch Inflation Device  30 atm/bar REF IN2130    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-0057-2025: Merit Medical Systems, Inc. is voluntarily recalling Monarch Inflation Device  30 atm/bar REF IN2130    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: IN2130/B UDI-DI code: 00884450298022 Lot Number: H2298616 H2305036 H2309344 H2320983 H2326311 H2331539 H2337133 H2343847 H2348708 H2353509 H2360153 H2363096 H2369555 H2379873 H2385821 H2385822 H2390615 H2395794 H2398306 H2398307 H2413093 H2416389 H2421990 H2426109 H2426110 H2432438 H2435891 H2435892 H2443005 H2443006 H2446111 H2446112 H2453677 H2457935 H2457936 H2462761 H2466451 H2474178 H2474381 H2478395 H2483315 H2486954 H2492842 H2497958 H2503845 H2507121 H2511931 H2517519 H2522879 H2528488 H2534959 H2540013 H2545412 H2550517 H2554636 H2560207 H2564558 H2568223 H2574050 H2579555 H2584202 H2589844 H2594942 H2599816 H2604241 H2610525 H2614055 H2618905 H2622810 H2629606 H2633300 H2639297 H2645652 H2649895 H2655508 H2660064 H2664660 H2669777 H2673568 H2673571 H2682478 H2688023 H2689404 H2701288 H2709365 H2721312 H2724409 H2733388 H2739474 H2746747 H2751182 H2755942 H2760545 H2761569 H2765632 H2769986 H2774664 H2774665 H2779111 H2789790 H2793108 H2819815 H2824760 H2830071 H2838428 H2838429 H2845202 H2847851 H2849886 H2856553 H2861490 H2867259 H2867398 H2871516 H2877375 H2886249 H2890795 H2900796 H2907141 H2912642 H2918427 H2925193 H2929404 H2934698 H2937984 H2943477 H2972585 H2982494 H3000024   Catalog Number: IN2130/JPB UDI-DI code: 00884450298022 Lot Number: H2298077 H2311498 H2318440 H2326018 H2335950 H2348220 H2361952 H2378902 H2397943 H2446311 H2457899 H2466518 H2511623 H2538830 H2617878 H2632026 H2645098 H2709628 H2721346 H2739491 H2746832 H2756147 H2765723 H2770192 H2790666 H2799040 H2806169 H2838478 H2845266  Catalog Number: K05-02130 UDI-DI code: 00884450047248 Lot Number: H2304639 H2326198 H2353301 H2360131 H2412972 H2443283 H2454607 H2473435 H2503267 H2516468 H2673631 H2708526 H2751266 H2756101 H2856665. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
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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-0057-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0057-2025&lang=eng"
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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-0057-2025/fda-classification",
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      "name": "FDA classified recall Z-0057-2025 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",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0057-2025&lang=eng"
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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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    {
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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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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": "Z-0057-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "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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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-30",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number: IN2130/B UDI-DI code: 00884450298022 Lot Number: H2298616 H2305036 H2309344 H2320983 H2326311 H2331539 H2337133 H2343847 H2348708 H2353509 H2360153 H2363096 H2369555 H2379873 H2385821 H2385822 H2390615 H2395794 H2398306 H2398307 H2413093 H2416389 H2421990 H2426109 H2426110 H2432438 H2435891 H2435892 H2443005 H2443006 H2446111 H2446112 H2453677 H2457935 H2457936 H2462761 H2466451 H2474178 H2474381 H2478395 H2483315 H2486954 H2492842 H2497958 H2503845 H2507121 H2511931 H2517519 H2522879 H2528488 H2534959 H2540013 H2545412 H2550517 H2554636 H2560207 H2564558 H2568223 H2574050 H2579555 H2584202 H2589844 H2594942 H2599816 H2604241 H2610525 H2614055 H2618905 H2622810 H2629606 H2633300 H2639297 H2645652 H2649895 H2655508 H2660064 H2664660 H2669777 H2673568 H2673571 H2682478 H2688023 H2689404 H2701288 H2709365 H2721312 H2724409 H2733388 H2739474 H2746747 H2751182 H2755942 H2760545 H2761569 H2765632 H2769986 H2774664 H2774665 H2779111 H2789790 H2793108 H2819815 H2824760 H2830071 H2838428 H2838429 H2845202 H2847851 H2849886 H2856553 H2861490 H2867259 H2867398 H2871516 H2877375 H2886249 H2890795 H2900796 H2907141 H2912642 H2918427 H2925193 H2929404 H2934698 H2937984 H2943477 H2972585 H2982494 H3000024   Catalog Number: IN2130/JPB UDI-DI code: 00884450298022 Lot Number: H2298077 H2311498 H2318440 H2326018 H2335950 H2348220 H2361952 H2378902 H2397943 H2446311 H2457899 H2466518 H2511623 H2538830 H2617878 H2632026 H2645098 H2709628 H2721346 H2739491 H2746832 H2756147 H2765723 H2770192 H2790666 H2799040 H2806169 H2838478 H2845266  Catalog Number: K05-02130 UDI-DI code: 00884450047248 Lot Number: H2304639 H2326198 H2353301 H2360131 H2412972 H2443283 H2454607 H2473435 H2503267 H2516468 H2673631 H2708526 H2751266 H2756101 H2856665",
            "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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}