{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2413-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)\t\tA22201C  2)\t\tA22201D  3)\t\tA22202C  4)\t\tA22203C  5)\t\tA22205C  6)\t\tA22205D  7)\t\tA22206C  8)\t\tA22207C  9)\t\tA22211C  10)\t\tA22221C  11)\t\tA22222C  12)\t\tA22223C  13)\t\tA22231C  14)\t\tA22231D  15)\t\tA22251C  16)\t\tA22253C  17)\t\tA22255C  18)\t\tA22257C  19)\t\tA22258C  20)\t\tA22266C  21)\t\tA44728C  22)\t\tWA22037C  23)\t\tWA22038C  24)\t\tWA22039C  25)\t\tWA22301D  26)\tWA22301S  27)\tWA22302D  28)\tWA22305D  29)\tWA22305S  30)\tWA22306D  31)\tWA22332D  32)\tWA22351C  33)\tWA22355C  34)\tWA22503D  35)\tWA22507D  36)\tWA22521C  37)\tWA22523C  38)\tWA22537D  39)\tWA22538C  40)\tWA22539D  41)\tWA22540S  42)\tWA22541S  43)\tWA22542S  44)\tWA22544S  45)\tWA22557C  46)\tWA22566S  47)\tWA22602D  48)\tWA22603D  49)\tWA22606D  50)\tWA22607D  51)\tWA22621C\t  52)\tWA22623C\t  53)\tWA22632D\t  54)\tWA22651C\t  55)\tWA22655C\t  56)\tWA22657C\t  57)\tWA47505S\t  58)\tWA47506S\t  59)\tWA47507S\t  60)\tWA47540S\t  61)\tWA47551S\t  62)\tWA47555S\t  63)\tWA47560S\t  64)\tWA47566S",
  "description": "FDA recall Z-2413-2023 — Olympus Corporation of the Americas is recalling HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)\t\tA22201C  2)\t\tA22201D  3)\t\tA22202C  4)\t\tA22203C  5)\t\tA22205C  6)\t\tA22205D  7)\t\tA22206C  8)\t\tA22207C  9)\t\tA22211C  10)\t\tA22221C  11)\t\tA22222C  12)\t\tA22223C  13)\t\tA22231C  14)\t\tA22231D  15)\t\tA22251C  16)\t\tA22253C  17)\t\tA22255C  18)\t\tA22257C  19)\t\tA22258C  20)\t\tA22266C  21)\t\tA44728C  22)\t\tWA22037C  23)\t\tWA22038C  24)\t\tWA22039C  25)\t\tWA22301D  26)\tWA22301S  27)\tWA22302D  28)\tWA22305D  29)\tWA22305S  30)\tWA22306D  31)\tWA22332D  32)\tWA22351C  33)\tWA22355C  34)\tWA22503D  35)\tWA22507D  36)\tWA22521C  37)\tWA22523C  38)\tWA22537D  39)\tWA22538C  40)\tWA22539D  41)\tWA22540S  42)\tWA22541S  43)\tWA22542S  44)\tWA22544S  45)\tWA22557C  46)\tWA22566S  47)\tWA22602D  48)\tWA22603D  49)\tWA22606D  50)\tWA22607D  51)\tWA22621C\t  52)\tWA22623C\t  53)\tWA22632D\t  54)\tWA22651C\t  55)\tWA22655C\t  56)\tWA22657C\t  57)\tWA47505S\t  58)\tWA47506S\t  59)\tWA47507S\t  60)\tWA47540S\t  61)\tWA47551S\t  62)\tWA47555S\t  63)\tWA47560S\t  64)\tWA47566S (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2413-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)\t\tA22201C  2)\t\tA22201D  3)\t\tA22202C  4)\t\tA22203C  5)\t\tA22205C  6)\t\tA22205D  7)\t\tA22206C  8)\t\tA22207C  9)\t\tA22211C  10)\t\tA22221C  11)\t\tA22222C  12)\t\tA22223C  13)\t\tA22231C  14)\t\tA22231D  15)\t\tA22251C  16)\t\tA22253C  17)\t\tA22255C  18)\t\tA22257C  19)\t\tA22258C  20)\t\tA22266C  21)\t\tA44728C  22)\t\tWA22037C  23)\t\tWA22038C  24)\t\tWA22039C  25)\t\tWA22301D  26)\tWA22301S  27)\tWA22302D  28)\tWA22305D  29)\tWA22305S  30)\tWA22306D  31)\tWA22332D  32)\tWA22351C  33)\tWA22355C  34)\tWA22503D  35)\tWA22507D  36)\tWA22521C  37)\tWA22523C  38)\tWA22537D  39)\tWA22538C  40)\tWA22539D  41)\tWA22540S  42)\tWA22541S  43)\tWA22542S  44)\tWA22544S  45)\tWA22557C  46)\tWA22566S  47)\tWA22602D  48)\tWA22603D  49)\tWA22606D  50)\tWA22607D  51)\tWA22621C\t  52)\tWA22623C\t  53)\tWA22632D\t  54)\tWA22651C\t  55)\tWA22655C\t  56)\tWA22657C\t  57)\tWA47505S\t  58)\tWA47506S\t  59)\tWA47507S\t  60)\tWA47540S\t  61)\tWA47551S\t  62)\tWA47555S\t  63)\tWA47560S\t  64)\tWA47566S",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2413-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2413-2023: Olympus Corporation of the Americas is recalling HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)\t\tA22201C  2)\t\tA22201D  3)\t\tA22202C  4)\t\tA22203C  5)\t\tA22205C  6)\t\tA22205D  7)\t\tA22206C  8)\t\tA22207C  9)\t\tA22211C  10)\t\tA22221C  11)\t\tA22222C  12)\t\tA22223C  13)\t\tA22231C  14)\t\tA22231D  15)\t\tA22251C  16)\t\tA22253C  17)\t\tA22255C  18)\t\tA22257C  19)\t\tA22258C  20)\t\tA22266C  21)\t\tA44728C  22)\t\tWA22037C  23)\t\tWA22038C  24)\t\tWA22039C  25)\t\tWA22301D  26)\tWA22301S  27)\tWA22302D  28)\tWA22305D  29)\tWA22305S  30)\tWA22306D  31)\tWA22332D  32)\tWA22351C  33)\tWA22355C  34)\tWA22503D  35)\tWA22507D  36)\tWA22521C  37)\tWA22523C  38)\tWA22537D  39)\tWA22538C  40)\tWA22539D  41)\tWA22540S  42)\tWA22541S  43)\tWA22542S  44)\tWA22544S  45)\tWA22557C  46)\tWA22566S  47)\tWA22602D  48)\tWA22603D  49)\tWA22606D  50)\tWA22607D  51)\tWA22621C\t  52)\tWA22623C\t  53)\tWA22632D\t  54)\tWA22651C\t  55)\tWA22655C\t  56)\tWA22657C\t  57)\tWA47505S\t  58)\tWA47506S\t  59)\tWA47507S\t  60)\tWA47540S\t  61)\tWA47551S\t  62)\tWA47555S\t  63)\tWA47560S\t  64)\tWA47566S",
      "text": "The FDA logged enforcement record Z-2413-2023: Olympus Corporation of the Americas is voluntarily recalling HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications.    64 Models:  1)\t\tA22201C  2)\t\tA22201D  3)\t\tA22202C  4)\t\tA22203C  5)\t\tA22205C  6)\t\tA22205D  7)\t\tA22206C  8)\t\tA22207C  9)\t\tA22211C  10)\t\tA22221C  11)\t\tA22222C  12)\t\tA22223C  13)\t\tA22231C  14)\t\tA22231D  15)\t\tA22251C  16)\t\tA22253C  17)\t\tA22255C  18)\t\tA22257C  19)\t\tA22258C  20)\t\tA22266C  21)\t\tA44728C  22)\t\tWA22037C  23)\t\tWA22038C  24)\t\tWA22039C  25)\t\tWA22301D  26)\tWA22301S  27)\tWA22302D  28)\tWA22305D  29)\tWA22305S  30)\tWA22306D  31)\tWA22332D  32)\tWA22351C  33)\tWA22355C  34)\tWA22503D  35)\tWA22507D  36)\tWA22521C  37)\tWA22523C  38)\tWA22537D  39)\tWA22538C  40)\tWA22539D  41)\tWA22540S  42)\tWA22541S  43)\tWA22542S  44)\tWA22544S  45)\tWA22557C  46)\tWA22566S  47)\tWA22602D  48)\tWA22603D  49)\tWA22606D  50)\tWA22607D  51)\tWA22621C\t  52)\tWA22623C\t  53)\tWA22632D\t  54)\tWA22651C\t  55)\tWA22655C\t  56)\tWA22657C\t  57)\tWA47505S\t  58)\tWA47506S\t  59)\tWA47507S\t  60)\tWA47540S\t  61)\tWA47551S\t  62)\tWA47555S\t  63)\tWA47560S\t  64)\tWA47566S — reason: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-08. Affected lots/codes: #  Model UDI(DI)  1)  A22201C 14042761036648  2)  A22201D 14042761036655  3)  A22202C 14042761036662  4)  A22203C 14042761036686  5)  A22205C 14042761036709  6)  A22205D 14042761036716  7)  A22206C 14042761036723  8)  A22207C 14042761036747  9)  A22211C 14042761036761  10)  A22221C 14042761029466  11)  A22222C 14042761030431  12)  A22223C 14042761029770  13)  A22231C 14042761036778  14)  A22231D 14042761036785  15)  A22251C 14042761036815  16)  A22253C 14042761036822  17)  A22255C 14042761036839  18)  A22257C 14042761030448  19)  A22258C 14042761036853  20)  A22266C 14042761036891  21)  A44728C 14042761039090  22)  WA22037C 14042761051566  23)  WA22038C 14042761051580  24)  WA22039C 14042761051603  25)  WA22301D 14042761051658  26) WA22301S 14042761082386 27) WA22302D 14042761051665 28) WA22305D 14042761051672 29) WA22305S 14042761082393 30) WA22306D 14042761051689 31) WA22332D 14042761051702 32) WA22351C 14042761051719 33) WA22355C 14042761051719 34) WA22503D 14042761068205 35) WA22507D 14042761068236 36) WA22521C 14042761068243 37) WA22523C 14042761068267 38) WA22537D 14042761073940 39) WA22538C 14042761073964 40) WA22539D 14042761073971 41) WA22540S 14042761083710 42) WA22541S 14042761083727 43) WA22542S 14042761083734 44) WA22544S 14042761083758 45) WA22557C 14042761068342 46) WA22566S 14042761083765 47) WA22602D 14042761075456 48) WA22603D 14042761075463 49) WA22606D 14042761075470 50) WA22607D 14042761075487 51) WA22621C  14042761075494  52) WA22623C  14042761075500  53) WA22632D  14042761075517  54) WA22651C  14042761075524  55) WA22655C  14042761075531  56) WA22657C  14042761075548  57) WA47505S  14042761085035  58) WA47506S  14042761085042  59) WA47507S  14042761085073  60) WA47540S  14042761085103  61) WA47551S  14042761085059  62) WA47555S  14042761085066  63) WA47560S  14042761085080  64) WA47566S  14042761085097    All lot numbers. 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-2413-2023&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-2413-2023&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-2413-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2413-2023 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-2413-2023&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-2413-2023&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-2413-2023/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
      },
      "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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-2413-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2413-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Olympus Corporation of the Americas",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-06-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "#  Model UDI(DI)  1)  A22201C 14042761036648  2)  A22201D 14042761036655  3)  A22202C 14042761036662  4)  A22203C 14042761036686  5)  A22205C 14042761036709  6)  A22205D 14042761036716  7)  A22206C 14042761036723  8)  A22207C 14042761036747  9)  A22211C 14042761036761  10)  A22221C 14042761029466  11)  A22222C 14042761030431  12)  A22223C 14042761029770  13)  A22231C 14042761036778  14)  A22231D 14042761036785  15)  A22251C 14042761036815  16)  A22253C 14042761036822  17)  A22255C 14042761036839  18)  A22257C 14042761030448  19)  A22258C 14042761036853  20)  A22266C 14042761036891  21)  A44728C 14042761039090  22)  WA22037C 14042761051566  23)  WA22038C 14042761051580  24)  WA22039C 14042761051603  25)  WA22301D 14042761051658  26) WA22301S 14042761082386 27) WA22302D 14042761051665 28) WA22305D 14042761051672 29) WA22305S 14042761082393 30) WA22306D 14042761051689 31) WA22332D 14042761051702 32) WA22351C 14042761051719 33) WA22355C 14042761051719 34) WA22503D 14042761068205 35) WA22507D 14042761068236 36) WA22521C 14042761068243 37) WA22523C 14042761068267 38) WA22537D 14042761073940 39) WA22538C 14042761073964 40) WA22539D 14042761073971 41) WA22540S 14042761083710 42) WA22541S 14042761083727 43) WA22542S 14042761083734 44) WA22544S 14042761083758 45) WA22557C 14042761068342 46) WA22566S 14042761083765 47) WA22602D 14042761075456 48) WA22603D 14042761075463 49) WA22606D 14042761075470 50) WA22607D 14042761075487 51) WA22621C  14042761075494  52) WA22623C  14042761075500  53) WA22632D  14042761075517  54) WA22651C  14042761075524  55) WA22655C  14042761075531  56) WA22657C  14042761075548  57) WA47505S  14042761085035  58) WA47506S  14042761085042  59) WA47507S  14042761085073  60) WA47540S  14042761085103  61) WA47551S  14042761085059  62) WA47555S  14042761085066  63) WA47560S  14042761085080  64) WA47566S  14042761085097    All lot numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}