{
  "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": [
    {
      "status": "Terminated",
      "city": "North Haven",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79905",
      "recalling_firm": "Covidien LLC",
      "address_1": "60 Middletown Ave",
      "address_2": "N/A",
      "postal_code": "06473-3908",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA.   The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Indonesia, Italy, Korea, Malaysia, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, UK, and Vietnam.",
      "recall_number": "Z-1528-2018",
      "product_description": "EEA\" Hemorrhoid and Prolapse Stapler Set with DST Series\" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560    Product Usage:  The EEA  Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST  staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA  Hemorrhoid and prolapse stapler set with DST Series  Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA  Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.",
      "product_quantity": "475",
      "reason_for_recall": "There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.",
      "recall_initiation_date": "20180409",
      "center_classification_date": "20180426",
      "termination_date": "20200512",
      "report_date": "20180502",
      "code_info": "Lots: N7K0694MX, N7L1078MX, N7M0837MX"
    }
  ]
}