{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139883",
      "product_res_number": "Z-0105-2016",
      "event_date_initiated": "2015-09-01",
      "event_date_posted": "2015-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-01-29",
      "res_event_number": "72107",
      "product_code": "HEE",
      "k_numbers": [
        "K910253"
      ],
      "product_description": "CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure\nP/N 6061",
      "code_info": "LOT 187889",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "75 Corporate Dr",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-1350",
      "additional_info_contact": "SAME\n203-601-5200",
      "reason_for_recall": "Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains  vials Lidocaine HCl (1%)",
      "root_cause_description": "Labeling Change Control",
      "action": "CooperSurgical issued an \"Recall Notification\" dated September 1, 2015, to all affected customers  via FedEX with confirmed delivery receipt. The letter identified the product, the problem, and the action needed to be taken by the customer.\n\nCustomers asked to discontinue use of affected products and complete the attached Acknowledgement and Receipt Form for a free replacement.\n\nContact Product Surveillance at 203.601.5200 ext. 3300",
      "product_quantity": "305 units",
      "distribution_pattern": "US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.",
      "openfda": {
        "k_number": [
          "K910253",
          "K910252",
          "K983897",
          "K000117",
          "K052365",
          "K973671",
          "K021224",
          "K954718",
          "K980238"
        ],
        "registration_number": [
          "1222993",
          "1216677",
          "2245304",
          "1224960",
          "3032109",
          "3010155661",
          "3009401905",
          "1423507"
        ],
        "fei_number": [
          "3001238683",
          "3008002452",
          "1216677",
          "2245304",
          "3010155661",
          "3009401905",
          "1000120578",
          "3000204727"
        ],
        "device_name": "Set, Anesthesia, Paracervical",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5100",
        "device_class": "2"
      }
    }
  ]
}