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  "name": "ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.  Model #: Gen 4",
  "description": "FDA recall Z-2393-2023 — Cytrellis Biosystems, Inc. is recalling ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.  Model #: Gen 4 (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2393-2023&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.  Model #: Gen 4",
    "manufacturer": {
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      "name": "Cytrellis Biosystems, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2393-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2393-2023: Cytrellis Biosystems, Inc. is recalling ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.  Model #: Gen 4",
      "text": "The FDA logged enforcement record Z-2393-2023: Cytrellis Biosystems, Inc. is voluntarily recalling ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.  Model #: Gen 4 — reason: Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-23. Affected lots/codes: UDI = B933ELCON010 S/N:  SN 0101 0102 0103 0104 0105 0106 0107 0109 0111 0112 0113 0114 0115 0116 0117 0118 0119 0120 0121 0124 0126 0127 0128 0129 0130 0131 0132 0133 0134 0135 0136 0137 0138 0139 0140 0141 0142 0145 0146 0147 0148 0149 0151 0152 0153 0154 0155 0156 0157 0158 0160 0161 0162 0163 0165 0166 0167 0168 0169 0170 0172 0173 0174 0175 0177 0178 0179 0180 0181 0183 0184 0185 0186 0187 0188 0189 0190 0191 0192 0195 0196 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0211 0212 0213 0214 0215 0216 0218 0219 0220 0221 0222 0223 0224 0225 0226 0227 0228 0229 0231 0235 0236 0239 0240 0241 0242 0243 0244 0246 0247 0248 0249 0252 0254. A RECORDED FDA enforcement action (occurred=true).",
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      "commercialInfluence": false,
      "epistemicStatus": {
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        "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-2393-2023&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-2393-2023&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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      "name": "FDA classified recall Z-2393-2023 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.",
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        "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-2393-2023&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-2393-2023/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.",
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      "reviewStatus": "current",
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        "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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            "Field": "Classification",
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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Cytrellis Biosystems, Inc.",
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          "item": {
            "Field": "Reason",
            "Value": "Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring",
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            "Field": "Initiated",
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            "Value": "UDI = B933ELCON010 S/N:  SN 0101 0102 0103 0104 0105 0106 0107 0109 0111 0112 0113 0114 0115 0116 0117 0118 0119 0120 0121 0124 0126 0127 0128 0129 0130 0131 0132 0133 0134 0135 0136 0137 0138 0139 0140 0141 0142 0145 0146 0147 0148 0149 0151 0152 0153 0154 0155 0156 0157 0158 0160 0161 0162 0163 0165 0166 0167 0168 0169 0170 0172 0173 0174 0175 0177 0178 0179 0180 0181 0183 0184 0185 0186 0187 0188 0189 0190 0191 0192 0195 0196 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0211 0212 0213 0214 0215 0216 0218 0219 0220 0221 0222 0223 0224 0225 0226 0227 0228 0229 0231 0235 0236 0239 0240 0241 0242 0243 0244 0246 0247 0248 0249 0252 0254",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide",
            "Status": "recorded"
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