{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "North Haven",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91650",
      "recalling_firm": "Covidien, LP",
      "address_1": "60 Middletown Ave",
      "address_2": "",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Arkansas, California,  Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark,  Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway,  Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.",
      "recall_number": "Z-1228-2023",
      "product_description": "Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT",
      "product_quantity": "264 US; 5056 OUS",
      "reason_for_recall": "Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.",
      "recall_initiation_date": "20230125",
      "center_classification_date": "20230306",
      "report_date": "20230315",
      "code_info": "UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y",
      "more_code_info": ""
    }
  ]
}