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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1905-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412  TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413  TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414  TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415  TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190",
  "description": "FDA recall Z-1905-2024 — Stryker Neurovascular is recalling Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412  TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413  TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414  TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415  TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190 (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "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-1905-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412  TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413  TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414  TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415  TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Stryker Neurovascular"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1905-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1905-2024: Stryker Neurovascular is recalling Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412  TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413  TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414  TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415  TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190",
      "text": "The FDA logged enforcement record Z-1905-2024: Stryker Neurovascular is voluntarily recalling Trevo NXT ProVue 3 x 32, US, Catalog: 90312    Kits:  TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412  TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413  TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414  TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415  TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416  TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170  TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190 — reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-23. Affected lots/codes: Catalog/UDI-DI/Lot:   90312/07613327299922/118881;  91412/07613327500684/48483279, 48483281, 48483294, 48696618, 48696619, 48696620, 48715713, 48834692, 48834695, 48834696;  91413/07613327500691/48483280, 48483284, 48483289, 48483291, 48483316, 48483317, 48696613, 48696622, 48696623, 48715711, 48715715;  91414/07613327500707/48447776, 48447778, 48447779, 48483290, 48483292, 48483293, 48483315, 48483318, 48483320, 48696624, 48715714, 48834690, 48834691, 48834694, 48834697, 48852726, 48852730, 48852731, 48852732, 48852734, 48852735, 48852737, 48852738;  91415/07613327500714/48483277, 48483283, 48483295, 48483296, 48483311, 48483312, 48696621, 48715712, 48715716, 48834688, 48834693, 48834698;  91416/07613327507904/47328863, 47328865, 47351815, 47351816, 47374814, 48500988, 48501006, 48501007, 48501008, 48501009, 48501010, 48501011, 48501012, 48501013, 48501014, 48540277, 48556780, 48556783, 48558375, 48588482, 48589876, 48641524, 50065509, 50065520, 50193572, 50260581, 50327385, 50327403, 50375186, 50375187, 50422577, 50422588, 50448274, 50738892, 50762691, 50762721, 50762722, 50786687, 50797491, 50797494, 50797495, 50886508, 51320490, 51320491, 51379394, 51379399, 51379400, 51379401, 51379402, 51379403, 51379404, 51379405, 51379406, 51379408, 51467927, 51489221, 51489230, 51489233, 51489234;  SFP914170/07613327508055/48834689;  SFP914190/07613327508079/48945914. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1905-2024&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-1905-2024&lang=eng"
        }
      },
      "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-1905-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1905-2024 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,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1905-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "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-1905-2024&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-1905-2024/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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1905-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1905-2024",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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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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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Stryker Neurovascular",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-23",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog/UDI-DI/Lot:   90312/07613327299922/118881;  91412/07613327500684/48483279, 48483281, 48483294, 48696618, 48696619, 48696620, 48715713, 48834692, 48834695, 48834696;  91413/07613327500691/48483280, 48483284, 48483289, 48483291, 48483316, 48483317, 48696613, 48696622, 48696623, 48715711, 48715715;  91414/07613327500707/48447776, 48447778, 48447779, 48483290, 48483292, 48483293, 48483315, 48483318, 48483320, 48696624, 48715714, 48834690, 48834691, 48834694, 48834697, 48852726, 48852730, 48852731, 48852732, 48852734, 48852735, 48852737, 48852738;  91415/07613327500714/48483277, 48483283, 48483295, 48483296, 48483311, 48483312, 48696621, 48715712, 48715716, 48834688, 48834693, 48834698;  91416/07613327507904/47328863, 47328865, 47351815, 47351816, 47374814, 48500988, 48501006, 48501007, 48501008, 48501009, 48501010, 48501011, 48501012, 48501013, 48501014, 48540277, 48556780, 48556783, 48558375, 48588482, 48589876, 48641524, 50065509, 50065520, 50193572, 50260581, 50327385, 50327403, 50375186, 50375187, 50422577, 50422588, 50448274, 50738892, 50762691, 50762721, 50762722, 50786687, 50797491, 50797494, 50797495, 50886508, 51320490, 51320491, 51379394, 51379399, 51379400, 51379401, 51379402, 51379403, 51379404, 51379405, 51379406, 51379408, 51467927, 51489221, 51489230, 51489233, 51489234;  SFP914170/07613327508055/48834689;  SFP914190/07613327508079/48945914",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}