{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
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  },
  "results": [
    {
      "cfres_id": "181546",
      "product_res_number": "Z-2252-2020",
      "event_date_initiated": "2020-05-12",
      "event_date_created": "2020-06-03",
      "recall_status": "Open, Classified",
      "res_event_number": "85689",
      "product_code": "GCI",
      "k_numbers": [
        "K912097"
      ],
      "product_description": "Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).",
      "code_info": "Lots P9J0241Y   P9J0242Y   P9J0243Y   P9K1140Y                  P9K1663Y                  P9K1141Y",
      "firm_fei_number": "1282497",
      "recalling_firm": "Covidien Llc",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "additional_info_contact": "Medtronic Post Market Vigilance\n508-261-8000",
      "reason_for_recall": "The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.",
      "root_cause_description": "Process control",
      "action": "All consignees were notified by letter titled \"Urgent Medical Device Recall\" delivered via Federal Express and/or certified mail beginning May 12, 2020. The letter informs customers of the recall of specific item codes and production lots of Multifire hernia staplers due to a manufacturing assembly error. Use of a device with this condition may result in the failure of staples to properly advance within the staple cartridge when the instrument handle is compressed.\n\nCustomers are instructed to take the following actions:\n\" Immediately quarantine and discontinue use of the affected item code and lot.\n\" Return affected product.\n\" Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected product.\n\" Complete the Recalled Product Return Form even if you do not have inventory.\n\nIf you have any questions about this event, you may contact Medtronic via email at rs.assurancequality@medtronic.com",
      "product_quantity": "12,610 total",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K911461",
          "K914120",
          "K896205",
          "K021747",
          "K930302",
          "K905117",
          "K911829",
          "K930496",
          "K922123",
          "K001362",
          "K915762",
          "K920139",
          "K003222",
          "K933515"
        ],
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          "3017636737",
          "3021632375",
          "3013665681",
          "3010493171",
          "3016555232",
          "3014479313"
        ],
        "device_name": "Laryngoscope, Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}