{
  "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": "Mansfield",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87618",
      "recalling_firm": "Covidien Llc",
      "address_1": "15 Hampshire St",
      "address_2": "N/A",
      "postal_code": "02048-1113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX",
      "recall_number": "Z-1419-2021",
      "product_description": "Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.  Product Number: SIGTRSB60AMT",
      "product_quantity": "222 units",
      "reason_for_recall": "Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch",
      "recall_initiation_date": "20210323",
      "center_classification_date": "20210413",
      "termination_date": "20240515",
      "report_date": "20210421",
      "code_info": "Lot Number: N0M0801RY  Exp. Date: ¿11/30/2023    UDI: A8845217176201 20884521717623"
    }
  ]
}