{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Misgav",
      "state": "N/A",
      "country": "Israel",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86483",
      "recalling_firm": "Gordian Surgical",
      "address_1": "Tchelet 17, Trendlines Building, Misgav",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution including in the states of Texas and Michigan.",
      "recall_number": "Z-0398-2021",
      "product_description": "TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.",
      "product_quantity": "300 total devices",
      "reason_for_recall": "Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).",
      "recall_initiation_date": "20200922",
      "center_classification_date": "20201103",
      "termination_date": "20210211",
      "report_date": "20201111",
      "code_info": "Catalog Number: GSTC1200  Lot Numbers:  AS200009/3, Exp 14 FEB 2022  AS200012/4, Exp 23 MAR 2022"
    }
  ]
}