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  "name": "Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.    The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.  Component: No",
  "description": "FDA recall Z-0657-2025 — Kirwan Surgical Products, LLC is recalling Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.    The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.  Component: No (Devices, Class I). 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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.    The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.  Component: No",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Kirwan Surgical Products, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0657-2025/enforcement-record",
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      "name": "FDA recall Z-0657-2025: Kirwan Surgical Products, LLC is recalling Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.    The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.  Component: No",
      "text": "The FDA logged enforcement record Z-0657-2025: Kirwan Surgical Products, LLC is voluntarily recalling Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.    The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedures. The current line of pencils all have the same molded handle. The pencils' tip outer diameter is 25 gauge.  Component: No — reason: Potential for the outer stainless-steel tube to break or detach.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-14. Affected lots/codes: Model/Catalog Number: PD7226.  GTINs: Pouch - 00190660001025, Inner Pack - 10190660001022.  All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "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-0657-2025&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-0657-2025&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-0657-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-0657-2025/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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        "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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            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Kirwan Surgical Products, LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Potential for the outer stainless-steel tube to break or detach.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-11-14",
            "Status": "recorded"
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            "Value": "Model/Catalog Number: PD7226.  GTINs: Pouch - 00190660001025, Inner Pack - 10190660001022.  All expiration dates from 2027-09-01(YYYY-MM_DD) on would encompass the for the recall.",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide including PUERTO RICO; AUSTRALIA, CANADA, CHILE, COLOMBIA, DENMARK, EGYPT, ENGLAND, FRANCE, GERMANY, ISRAEL, ITALY, JAPAN, MEXICO, NETHERLANDS, PHILIPPINES, SOUTH AFRICA, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, and VENEZUELA.",
            "Status": "recorded"
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