{
  "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": "2711 kits",
      "code_info": "Kit Lot numbers:  00B0203  00Z1924  00Z1992  00Z1993  00Z2030  00Z2062  00Z2063  00Z2072  00Z2081  00Z2090  00Z2098  00Z2117  00Z2119  00Z2121  00Z2122  00Z2123  00Z2124  00Z2129  00Z2130  00Z2133  00Z2138  00Z2139  00Z2143  00Z2145  00Z2146  00Z2147  00Z2148  00Z2150  00Z2151  00Z2152  00Z2153  00Z2154  00Z2155  00Z2159  00Z2160  00Z2161  00Z2163  00Z2164  00Z2166  00Z2167  00Z2171  00Z2172  00Z2174  00Z2175  00Z2176  00Z2177  00Z2179  00Z2181  00Z2182  00Z2183  00Z2184  00Z2187  00Z2190  00Z2191  00Z2192  00Z2193  00Z2194  00Z2198  00Z2199  00Z2200  00Z2201  00Z2208  00Z2209  00Z2211  00Z2212  00Z2213  00Z2216  00Z2217  00Z2220  00Z2221  00Z2222  00Z2223  00Z2224  00Z2225  00Z2233  00Z2234  00Z2237  00Z2243  00Z2244  00Z2245  00Z2249  00Z2252  00Z2254  00Z2255  00Z2265  00Z2268  00Z2272  00Z2273  00Z2287  00Z2289  00Z2304  00Z2305  00Z2306  00Z2312  00Z2315  00Z2321  00Z2322  00Z2323  00Z2325  00Z2326  00Z2327  00Z2328  00Z2351  00Z2352  00Z2353  00Z2367  00Z2391  00Z2392  00Z2396  00Z2432  00Z5001  00Z5001A  BARIATRICRR1  BARIATRICRR5  BARIATRICRR7  ENDOBARIATRICR  ENDOBARIATRICS  ENDOTHORACICL  ENDOTHORACICS  ENDOTHORACICW  THORACICRR1  00Z2363  00Z2364  00Z2387",
      "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": "Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles    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\u001d Ultra Universal Short, Endo GIA\u001d Ultra Universal and Endo GIA\u001d Ultra Universal XL staplers when used with the Endo GIA\u001d 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-0822-2016",
      "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"
    }
  ]
}