{
  "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": "364,768 units",
      "code_info": "RANGES OF LOT NUMBERS  (all lot numbers within each range are affected)  Lot # starting with P3C through P5B0289X   P5C0196X through P5C0197X   P5C0304X through P5C0307X   P5C0796X through P5C0798X   P5D0049X through P5D0051X   P5D0146X through P5D0148X   P5E0261X through P5E0262X   P5F0158X through P5F0161X    INDIVIDUAL LOT NUMBERS  (in addition to ranges)  N3F0260RX                  N3F0266RX                  N3F0267RX  P5C0201X  P5D0538X   P5E0680X   P5E0682X   P5E0686X  P5E0760X  P5E0762X                    P5E0765X",
      "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 Short Stapler Handle  Ref: EGIAUSHORT    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-0819-2016",
      "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"
    }
  ]
}