{
  "@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-2283-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: HiResolution\" Bionic Ear System  Product Name: HiRes Ultra 3D CI HiFocus Mid Scala  Model/Catalog Number: CI-1601-04  Software Version: N/A  Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes\" Ultra 3D receiver and either the HiFocus\" SlimJ electrode or the HiFocus\" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.  Component: N/A",
  "description": "FDA recall Z-2283-2026 — Advanced Bionics, LLC is recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: HiRes Ultra 3D CI HiFocus Mid Scala  Model/Catalog Number: CI-1601-04  Software Version: N/A  Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes\" Ultra 3D receiver and either the HiFocus\" SlimJ electrode or the HiFocus\" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.  Component: N/A (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-2283-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: HiResolution\" Bionic Ear System  Product Name: HiRes Ultra 3D CI HiFocus Mid Scala  Model/Catalog Number: CI-1601-04  Software Version: N/A  Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes\" Ultra 3D receiver and either the HiFocus\" SlimJ electrode or the HiFocus\" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.  Component: N/A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Advanced Bionics, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2283-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2283-2026: Advanced Bionics, LLC is recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: HiRes Ultra 3D CI HiFocus Mid Scala  Model/Catalog Number: CI-1601-04  Software Version: N/A  Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes\" Ultra 3D receiver and either the HiFocus\" SlimJ electrode or the HiFocus\" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.  Component: N/A",
      "text": "The FDA logged enforcement record Z-2283-2026: Advanced Bionics, LLC is voluntarily recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: HiRes Ultra 3D CI HiFocus Mid Scala  Model/Catalog Number: CI-1601-04  Software Version: N/A  Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes\" Ultra 3D receiver and either the HiFocus\" SlimJ electrode or the HiFocus\" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound.  Component: N/A — reason: Due to incorrect shelf-life expiration date.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-30. Affected lots/codes: Model Number: CI-1601-04 UDI codes: (01)00840094455993(11)260220(17)290228(21)2225141 (01)00840094455993(11)260220(17)290228(21)2225150 (01)00840094455993(11)260220(17)290228(21)2225152 (01)00840094455993(11)260220(17)290228(21)2225155 (01)00840094455993(11)260220(17)290228(21)2225160 (01)00840094455993(11)260220(17)290228(21)2225188 (01)00840094455993(11)250929(17)280930(21)2227161 (01)00840094455993(11)260309(17)290331(21)2229827 (01)00840094455993(11)260309(17)290331(21)2229839 (01)00840094455993(11)260309(17)290331(21)2229849 (01)00840094455993(11)250918(17)280930(21)2214172 (01)00840094455993(11)260220(17)290228(21)2225146 (01)00840094455993(11)260220(17)290228(21)2225154 (01)00840094455993(11)260220(17)290228(21)2225168 (01)00840094455993(11)260220(17)290228(21)2225189 (01)00840094455993(11)250929(17)280930(21)2226476 (01)00840094455993(11)250929(17)280930(21)2227006 (01)00840094455993(11)250929(17)280930(21)2227007 (01)00840094455993(11)250929(17)280930(21)2227012 (01)00840094455993(11)250929(17)280930(21)2227038 (01)00840094455993(11)250929(17)280930(21)2227071 (01)00840094455993(11)250929(17)280930(21)2227112 (01)00840094455993(11)250929(17)280930(21)2227122 (01)00840094455993(11)250929(17)280930(21)2227129 (01)00840094455993(11)250929(17)280930(21)2227148 (01)00840094455993(11)250929(17)280930(21)2227151 (01)00840094455993(11)250929(17)280930(21)2227183 (01)00840094455993(11)250929(17)280930(21)2227196 (01)00840094455993(11)250929(17)280930(21)2227202 (01)00840094455993(11)250929(17)280930(21)2227207 (01)00840094455993(11)250929(17)280930(21)2227212 (01)00840094455993(11)250929(17)280930(21)2227215 (01)00840094455993(11)250929(17)280930(21)2227220 (01)00840094455993(11)250929(17)280930(21)2227235 (01)00840094455993(11)260309(17)290331(21)2229803 (01)00840094455993(11)260309(17)290331(21)2229836 Lot Numbers: 2225141 2225150 2225152 2225155 2225160 2225188 2227161 2229827 2229839 2229849 2214172 2225146 2225154 2225168 2225189 2226476 2227006 2227007 2227012 2227038 2227071 2227112 2227122 2227129 2227148 2227151 2227183 2227196 2227202 2227207 2227212 2227215 2227220 2227235 2229803 2229836   Lot Code: Serial Number/UDI Refer to Exhibit_0005. 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-2283-2026&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-2283-2026&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-2283-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2283-2026 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-2283-2026&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-2283-2026&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-2283-2026/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-2283-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2283-2026",
            "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": "Advanced Bionics, LLC",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to incorrect shelf-life expiration date.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-04-30",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model Number: CI-1601-04 UDI codes: (01)00840094455993(11)260220(17)290228(21)2225141 (01)00840094455993(11)260220(17)290228(21)2225150 (01)00840094455993(11)260220(17)290228(21)2225152 (01)00840094455993(11)260220(17)290228(21)2225155 (01)00840094455993(11)260220(17)290228(21)2225160 (01)00840094455993(11)260220(17)290228(21)2225188 (01)00840094455993(11)250929(17)280930(21)2227161 (01)00840094455993(11)260309(17)290331(21)2229827 (01)00840094455993(11)260309(17)290331(21)2229839 (01)00840094455993(11)260309(17)290331(21)2229849 (01)00840094455993(11)250918(17)280930(21)2214172 (01)00840094455993(11)260220(17)290228(21)2225146 (01)00840094455993(11)260220(17)290228(21)2225154 (01)00840094455993(11)260220(17)290228(21)2225168 (01)00840094455993(11)260220(17)290228(21)2225189 (01)00840094455993(11)250929(17)280930(21)2226476 (01)00840094455993(11)250929(17)280930(21)2227006 (01)00840094455993(11)250929(17)280930(21)2227007 (01)00840094455993(11)250929(17)280930(21)2227012 (01)00840094455993(11)250929(17)280930(21)2227038 (01)00840094455993(11)250929(17)280930(21)2227071 (01)00840094455993(11)250929(17)280930(21)2227112 (01)00840094455993(11)250929(17)280930(21)2227122 (01)00840094455993(11)250929(17)280930(21)2227129 (01)00840094455993(11)250929(17)280930(21)2227148 (01)00840094455993(11)250929(17)280930(21)2227151 (01)00840094455993(11)250929(17)280930(21)2227183 (01)00840094455993(11)250929(17)280930(21)2227196 (01)00840094455993(11)250929(17)280930(21)2227202 (01)00840094455993(11)250929(17)280930(21)2227207 (01)00840094455993(11)250929(17)280930(21)2227212 (01)00840094455993(11)250929(17)280930(21)2227215 (01)00840094455993(11)250929(17)280930(21)2227220 (01)00840094455993(11)250929(17)280930(21)2227235 (01)00840094455993(11)260309(17)290331(21)2229803 (01)00840094455993(11)260309(17)290331(21)2229836 Lot Numbers: 2225141 2225150 2225152 2225155 2225160 2225188 2227161 2229827 2229839 2229849 2214172 2225146 2225154 2225168 2225189 2226476 2227006 2227007 2227012 2227038 2227071 2227112 2227122 2227129 2227148 2227151 2227183 2227196 2227202 2227207 2227212 2227215 2227220 2227235 2229803 2229836   Lot Code: Serial Number/UDI Refer to Exhibit_0005",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}