{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marshfield",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95753",
      "recalling_firm": "Kirwan Surgical Products, LLC",
      "address_1": "180 Enterprise Dr",
      "address_2": "",
      "postal_code": "02050-2110",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-0657-2025",
      "product_description": "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",
      "product_quantity": "4,470 units",
      "reason_for_recall": "Potential for the outer stainless-steel tube to break or detach.",
      "recall_initiation_date": "20241114",
      "center_classification_date": "20241216",
      "report_date": "20241225",
      "code_info": "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.",
      "more_code_info": ""
    }
  ]
}