{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "NORTH HAVEN",
      "address_1": "60 NIDDLETOWN AVE 2ND F",
      "reason_for_recall": "Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.",
      "address_2": "",
      "product_quantity": "171,271 units in total",
      "code_info": "Lot Numbers:  (1) 0214463634, 0215280952  (2) 0214013887, 0214144177,0214260194,0214470767,0214956044     0214620382, 0214744957, 0215079103, 0215151206",
      "center_classification_date": "20180706",
      "distribution_pattern": "Worldwide and US Nationwide",
      "state": "CT",
      "product_description": "(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143,\t\t\t  KITDE0143 BYPASS BOX)\t\t\t\t\t\t\t\t\t\t   (2) BOX KITDE0154 BYPASS KH NORDWEST   (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST\t\t\t\t  Product Usage:  The Endo GIA  universal and Endo GIA  universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA  universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.",
      "report_date": "20180523",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "COVIDIEN MEDTRONIC",
      "recall_number": "Z-1840-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79974",
      "termination_date": "20200617",
      "more_code_info": "",
      "recall_initiation_date": "20180426",
      "postal_code": "06473",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}