{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "131206",
      "product_res_number": "Z-0484-2015",
      "event_date_initiated": "2014-10-27",
      "event_date_posted": "2014-12-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-05-29",
      "res_event_number": "69636",
      "product_code": "HGI",
      "k_numbers": [
        "K905747"
      ],
      "product_description": "CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5\nModel Number(s): R2010\nIntended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.",
      "code_info": "Lot 159621 Exp Date: 2017-05",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "75 Vista Pl",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-3934",
      "additional_info_contact": "203-601-5200",
      "reason_for_recall": "Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode",
      "root_cause_description": "Packaging process control",
      "action": "CooperSurgical issued  recall letter dated  October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form.  Customers with questions were instructed to call 203-601-5200.",
      "product_quantity": "595 units",
      "distribution_pattern": "Worldwide Distribution - USA (Nationwide) and Internationally to  Canada, Portugal, and Hong Kong.",
      "openfda": {
        "k_number": [
          "K993527",
          "K974138",
          "K022593",
          "K940191",
          "K913213",
          "K905747",
          "K963653",
          "K944450",
          "K003608",
          "K922206",
          "K921791",
          "K971986",
          "K931338",
          "K895402",
          "K942986",
          "K905263",
          "K923570",
          "K952030",
          "K930132",
          "K921222",
          "K941251",
          "K121881",
          "K931541",
          "K152843",
          "K925478",
          "K061651",
          "K955093",
          "K993777",
          "K130606",
          "K002042",
          "K955756",
          "K963852",
          "K925333",
          "K965245",
          "K070877",
          "K931437",
          "K914329",
          "K982739",
          "K983840",
          "K925560",
          "K770295",
          "K921884",
          "K912046",
          "K952483",
          "K914367",
          "K770292",
          "K202915",
          "K923628",
          "K926179",
          "K963348",
          "K921386",
          "K961460",
          "K935634"
        ],
        "registration_number": [
          "3007728276",
          "1650907",
          "1720929",
          "1055236",
          "9610612",
          "1721686",
          "1054811",
          "3009103001",
          "3010041511",
          "1718873",
          "1320894",
          "3004519921",
          "1928237",
          "3010202439",
          "9680721",
          "9613793",
          "3015183635",
          "1836161",
          "3005646850",
          "3009903460",
          "3016245399",
          "1422634",
          "3013557562",
          "2020550",
          "1527736",
          "3011137372",
          "3005350457",
          "8040510",
          "1043214",
          "3032109",
          "2511556",
          "3004636440",
          "1721676",
          "3007421149",
          "8030607",
          "3011120183",
          "1720747",
          "2916714",
          "2183744",
          "1054241",
          "1651252",
          "2320762",
          "1450908",
          "1061927",
          "1216677",
          "3011989923",
          "3004491689",
          "3005075853",
          "1319639",
          "1721194",
          "2183715",
          "3010361165",
          "9710649",
          "1222773",
          "3014279513",
          "3013875599",
          "2032112",
          "3006638824",
          "1060680",
          "3011050570",
          "3001592626",
          "3003790304",
          "2246552",
          "1643817",
          "8043396",
          "3015173212"
        ],
        "fei_number": [
          "3007728276",
          "1720929",
          "1000514656",
          "1000208624",
          "1721686",
          "3009103001",
          "3006469671",
          "3010041511",
          "1718873",
          "1928237",
          "1000138054",
          "3006509795",
          "3005646850",
          "3015183635",
          "3002681132",
          "3002806315",
          "3009903460",
          "3016245399",
          "3013557562",
          "2020550",
          "1527736",
          "3003076831",
          "3005350457",
          "1000244733",
          "1000112968",
          "1043214",
          "2511556",
          "3004636440",
          "1721676",
          "3007421149",
          "3011120183",
          "1720747",
          "2916714",
          "2183744",
          "1000120768",
          "2246552",
          "3000203000",
          "1450908",
          "1000112877",
          "1216677",
          "3011989923",
          "1000114185",
          "3001451571",
          "3001319476",
          "3005747797",
          "3004491689",
          "3005075853",
          "3003565435",
          "2183715",
          "3010361165",
          "3002750084",
          "3014279513",
          "1721194",
          "3013875599",
          "3006638824",
          "3001238683",
          "3005846326",
          "3005461046",
          "3007475226",
          "3011050570",
          "3001592626",
          "3003790304",
          "3002770040",
          "1643817",
          "3015173212",
          "3003040625"
        ],
        "device_name": "Electrocautery, Gynecologic (And Accessories)",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.4120",
        "device_class": "2"
      }
    }
  ]
}