{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189193", "product_res_number": "Z-0260-2022", "event_date_initiated": "2021-09-29", "event_date_created": "2021-11-18", "recall_status": "Open, Classified", "res_event_number": "88648", "product_code": "HGI", "k_numbers": [ "K963653" ], "product_description": "LEEP PRECISION Generator 220V\nCooper Surgical Part Number: LP-20-220", "code_info": "Serial Numbers: 2018100001\t2018100002\t2018100003", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "Customer Service\n203-601-9818", "reason_for_recall": "Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.", "root_cause_description": "Component design/selection", "action": "CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take:\n\nThis Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you.\n Please feel free to reach us at 203-601-5200 ext. 3300.\n\nPlease complete this form and return it via email: recall@coopersurgical.com or fax to 203.601.9870\nATTN: Product Surveillance. CooperSurgical will arrange for a product repair after this form has been received.\n\nFirm issued additional letter for the product LP-10-220 as it was not included in the initial recall letter. The letter dated 10/18/21 distributed to international accounts only.", "product_quantity": "75 Units", "distribution_pattern": "US Nationwide Distribution\nForeign:\nARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM", "openfda": { "k_number": [ "K070877", "K923570", "K930132", "K963653", "K931541", "K914367", "K202915", "K925478", "K931338", "K913213", "K952483", "K982739", "K955093", "K952030", "K926179", "K921386", "K961460", "K941251", "K963348", "K121881", "K003608", "K130606", "K971986", "K925560", "K921222", "K921791", "K770295", "K905263", "K965245", "K942986", "K914329", "K895402", "K002042", "K963852", "K940191", "K935634", "K912046", "K923628", "K983840", "K993777", "K974138", "K061651", "K022593", "K921884", "K905747", "K955756", "K152843", "K770292", "K931437", "K925333", "K944450", "K922206", "K993527" ], "registration_number": [ "3032109", "8030607", "3005350457", "3016245399", "3004519921", "3007728276", "1054811", "3006638824", "3011050570", "3011989923", "3014279513", "1650907", "1721676", "1721194", "3009903460", "1718873", "1055236", "3015183635", "1043214", "9613793", "3011137372", "2916714", "1060680", "1054241", "9610612", "1643817", "8040510", "3001592626", "2183715", "1061927", "3015173212", "3010041511", "1527736", "9710649", "3007421149", "2032112", "1721686", "3005646850", "2020550", "3010202439", "3003790304", "1651252", "8043396", "1450908", "2320762", "1319639", "2183744", "3010361165", "3013557562", "2246552", "9680721", "1720747", "1422634", "2511556", "1320894", "1216677", "3004636440", "3009103001", "1836161", "3004491689", "3013875599", "1928237", "3011120183", "1720929", "1222773", "3005075853" ], "fei_number": [ "3005350457", "3016245399", "3007728276", "3002750084", "3003076831", "1000138054", "3011050570", "3011989923", "3006638824", "3014279513", "1721194", "1721676", "3001451571", "3002770040", "1000120768", "3009903460", "3003565435", "1718873", "3007475226", "3015183635", "1000208624", "3002681132", "2916714", "1043214", "1000112968", "1000514656", "1643817", "3001592626", "2183715", "1000244733", "3015173212", "3010041511", "1527736", "3007421149", "2020550", "3005646850", "1721686", "3001319476", "3003790304", "3003040625", "3005461046", "3000203000", "3001238683", "1450908", "3005846326", "2183744", "3010361165", "3013557562", "2246552", "1720747", "3005747797", "1000114185", "3002806315", "2511556", "1216677", "1000112877", "3004636440", "3009103001", "3004491689", "3013875599", "1928237", "3011120183", "3006509795", "1720929", "3006469671", "3005075853" ], "device_name": "Electrocautery, Gynecologic (And Accessories)", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4120", "device_class": "2" } } ] }