{
  "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": [
    {
      "country": "United States",
      "city": "Ponce",
      "address_1": "201 Sabanetas Industrial Park",
      "reason_for_recall": "Investigations related to customer complaints received for particulate matter inside of the Surgiwand\" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.",
      "address_2": "Building 911-67",
      "product_quantity": "59,828 devices",
      "code_info": "UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884  UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907  UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914",
      "center_classification_date": "20210412",
      "distribution_pattern": "Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.",
      "state": "PR",
      "product_description": "Covidien Surgiwand\" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22   Product Number/CFN: 178083, 178093, 178094",
      "report_date": "20210421",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Covidien",
      "recall_number": "Z-1411-2021",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "87542",
      "recall_initiation_date": "20210305",
      "postal_code": "00716",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}