{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "North Haven",
      "address_1": "60 Middletown Ave",
      "reason_for_recall": "Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use",
      "address_2": "",
      "product_quantity": "327,797 units",
      "code_info": "Lot numbers within each range are affected:  Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X.    Individual Lot Number: P5B0468X, P5E0523X, P5E0273X",
      "center_classification_date": "20160218",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.",
      "state": "CT",
      "product_description": "Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle  Ref: EGIAUXL    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.",
      "report_date": "20160224",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic",
      "recall_number": "Z-0821-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "72749",
      "termination_date": "20190718",
      "more_code_info": "",
      "recall_initiation_date": "20151202",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}