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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0627-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,  28MC21110ST/B,  28MC2113045/B,  28MC21130SN/CNB,  28MC21130ST/B,  28MC2115045/B,  28MC2115045/C,  28MC21150SN/B,  28MC21150ST/B,  28MC2411045/D,  28MC24110SN/D,  28MC24110ST/D,  28MC2413045/D,  28MC24130SN/F,  28MC24130ST/D,  28MC24130ST-W/A,  28MC2415045/D,  28MC24150ST/D,  28MC24150ST/F,  28MC28110ST/D,  28MC2813045/D,  28MC28130SN/D,  28MC28130SN/F,  28MC28130ST/D,  28MC28150SN/D,  28MC28150SN/F,  29MC2911045/D,  29MC29130SN/F,  29MC29130ST/D,  29MC29150ST/CNB,  29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY",
  "description": "FDA recall Z-0627-2024 — Merit Medical Systems, Inc. is recalling Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,  28MC21110ST/B,  28MC2113045/B,  28MC21130SN/CNB,  28MC21130ST/B,  28MC2115045/B,  28MC2115045/C,  28MC21150SN/B,  28MC21150ST/B,  28MC2411045/D,  28MC24110SN/D,  28MC24110ST/D,  28MC2413045/D,  28MC24130SN/F,  28MC24130ST/D,  28MC24130ST-W/A,  28MC2415045/D,  28MC24150ST/D,  28MC24150ST/F,  28MC28110ST/D,  28MC2813045/D,  28MC28130SN/D,  28MC28130SN/F,  28MC28130ST/D,  28MC28150SN/D,  28MC28150SN/F,  29MC2911045/D,  29MC29130SN/F,  29MC29130ST/D,  29MC29150ST/CNB,  29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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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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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0627-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,  28MC21110ST/B,  28MC2113045/B,  28MC21130SN/CNB,  28MC21130ST/B,  28MC2115045/B,  28MC2115045/C,  28MC21150SN/B,  28MC21150ST/B,  28MC2411045/D,  28MC24110SN/D,  28MC24110ST/D,  28MC2413045/D,  28MC24130SN/F,  28MC24130ST/D,  28MC24130ST-W/A,  28MC2415045/D,  28MC24150ST/D,  28MC24150ST/F,  28MC28110ST/D,  28MC2813045/D,  28MC28130SN/D,  28MC28130SN/F,  28MC28130ST/D,  28MC28150SN/D,  28MC28150SN/F,  29MC2911045/D,  29MC29130SN/F,  29MC29130ST/D,  29MC29150ST/CNB,  29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Merit Medical Systems, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0627-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0627-2024: Merit Medical Systems, Inc. is recalling Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,  28MC21110ST/B,  28MC2113045/B,  28MC21130SN/CNB,  28MC21130ST/B,  28MC2115045/B,  28MC2115045/C,  28MC21150SN/B,  28MC21150ST/B,  28MC2411045/D,  28MC24110SN/D,  28MC24110ST/D,  28MC2413045/D,  28MC24130SN/F,  28MC24130ST/D,  28MC24130ST-W/A,  28MC2415045/D,  28MC24150ST/D,  28MC24150ST/F,  28MC28110ST/D,  28MC2813045/D,  28MC28130SN/D,  28MC28130SN/F,  28MC28130ST/D,  28MC28150SN/D,  28MC28150SN/F,  29MC2911045/D,  29MC29130SN/F,  29MC29130ST/D,  29MC29150ST/CNB,  29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY",
      "text": "The FDA logged enforcement record Z-0627-2024: Merit Medical Systems, Inc. is voluntarily recalling Merit Maestro Microcatheter, Reference Numbers: \t28MC2111045/B,  28MC21110ST/B,  28MC2113045/B,  28MC21130SN/CNB,  28MC21130ST/B,  28MC2115045/B,  28MC2115045/C,  28MC21150SN/B,  28MC21150ST/B,  28MC2411045/D,  28MC24110SN/D,  28MC24110ST/D,  28MC2413045/D,  28MC24130SN/F,  28MC24130ST/D,  28MC24130ST-W/A,  28MC2415045/D,  28MC24150ST/D,  28MC24150ST/F,  28MC28110ST/D,  28MC2813045/D,  28MC28130SN/D,  28MC28130SN/F,  28MC28130ST/D,  28MC28150SN/D,  28MC28150SN/F,  29MC2911045/D,  29MC29130SN/F,  29MC29130ST/D,  29MC29150ST/CNB,  29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY — reason: The sterility of microcatheter and infusion system devices cannot be guaranteed.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-06. Affected lots/codes: Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215; Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239; Ref:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246; Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253; Ref:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260 Ref:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277 Ref:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456 Ref:28MC21150SN/B- Lot # H2750715 and H2769214 00884450335284 Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot # H2750372 00884450358207 Ref:28MC24130ST/D- Lot # H2750747 and H2779460  UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot # H2777603 00884450324592 Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI:  Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot # H2758290 00884450358085 Ref:29MC29130SN/F- Lot # H2750390 00884450358382 Ref:29MC29130ST/D- Lot # H2750599 00884450358139 Ref:29MC29150ST/CNB- Lot # H2756603 00884450038383 Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-0627-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-0627-2024&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0627-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0627-2024 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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-0627-2024&lang=eng"
        }
      },
      "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-0627-2024/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)",
        "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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      "name": "FDA recall details — Z-0627-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0627-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Merit Medical Systems, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The sterility of microcatheter and infusion system devices cannot be guaranteed.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-06",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215; Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239; Ref:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246; Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253; Ref:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260 Ref:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277 Ref:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456 Ref:28MC21150SN/B- Lot # H2750715 and H2769214 00884450335284 Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot # H2750372 00884450358207 Ref:28MC24130ST/D- Lot # H2750747 and H2779460  UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot # H2777603 00884450324592 Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI:  Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot # H2758290 00884450358085 Ref:29MC29130SN/F- Lot # H2750390 00884450358382 Ref:29MC29130ST/D- Lot # H2750599 00884450358139 Ref:29MC29150ST/CNB- Lot # H2756603 00884450038383 Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, \tKS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.",
            "Status": "recorded"
          }
        }
      ]
    }
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}