{ "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": "203738", "product_res_number": "Z-0502-2024", "event_date_initiated": "2022-03-31", "event_date_posted": "2023-12-06", "recall_status": "Open, Classified", "res_event_number": "93239", "product_code": "LKF", "k_numbers": [ "K961752" ], "product_description": "Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes.\nModel: 61-3005", "code_info": "UDI-DI: 60888937016408\nSN: 312868", "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": "Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure", "root_cause_description": "Component design/selection", "action": "CooperSurgical issued Urgent Medical Device Safety Notice dated March 22, 2023\nvia UPS Certified Delivery Mail. Letter states reason for recall, health risk and action to take:Our records indicate that you may have purchased the affected Product from CooperSurgical.\nPlease inspect stock and complete the attached Acknowledgement and Receipt Form. Once completed please return the form to CooperSurgical to acknowledge receipt of the notice. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice.\nA corrective action has been initiated to ensure this failure does not reoccur.\nWe sincerely apologize for any inconvenience caused by this notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at 203-601-5200 ext. 3300 or via email at Recall@coopersurgical.com.", "product_quantity": "73 units", "distribution_pattern": "Nationwide\nForeign:\nBELGIUM\nCANADA\nMALAYSIA\nNETHERLANDS\nSPAIN\nSWEDEN\nSWITZERLAND", "openfda": { "k_number": [ "K220202", "K130758", "K142545", "K941457", "K935023", "K212505", "K041062", "K013491", "K092980", "K020954", "K040238", "K071907", "K021272", "K772230", "K013437", "K932394", "K131781", "K931167", "K931122", "K902975", "K970492", "K933723", "K092984", "K955446", "K063611", "K935434", "K933981", "K943494", "K930038", "K123258", "K083594", "K071405", "K020951", "K102898", "K222798", "K941458", "K150519", "K001115", "K100662", "K171604", "K110288", "K940681", "K013972", "K160217", "K242002", "K142716", "K240364", "K946220", "K092983", "K953034", "K092969", "K931814", "K141523", "K083690", "K020292", "K022503", "K000433", "K932115", "K023051", "K904079", "K041094", "K930867", "K142164", "K061679", "K010296", "K955508", "K911887", "K181770", "K974357", "K093556", "K110993", "K010056", "K143415", "K253403", "K172846", "K223064", "K241693", "K252260", "K032835", "K163214", "K122820", "K153092", "K943448", "K961752", "K180291", "K932432", "K180300" ], "registration_number": [ "3015895045", "3010157088", "3005987240", "1718873", "1820334", "3015142721", "1220477", "3003968049", "3004215117", "2032098", "1421879", "1321175", "1018470", "3007800906", "3043226252", "3013557562", "3012627460", "3007421149", "3016678045", "1450908", "3004491689", "3009719225", "3008439467", "3020331900", "3024860690", "3042940623", "1720929", "9610612", "3032906574", "3013665681", "1450662", "3008770252", "3008254127", "3004727093", "1417485", "8040510", "3013868968", "3013077751", "1722684", "3016607092", "2528981", "3013283620", "3030447506", "3009328501", "1825146", "3004111573", "3014635169", "3012494290", "3015612252", "1627186", "3011063460", "3015224777", "3017619652", "2246552", "3016832577", "1625425", "3008571754", "3026606306", "3010041511", "1320894", "3007345416", "3017820152", "9680721", "3008367216", "3010701807", "1644312", "2431166", "3011137372", "1043214", "3032109", "1047843", "1412854", "1000393132", "2916714", "3025325116", "3008309062", "1216677", "3014663814", "1319639", "9611283", "1320468", "3001675293", "3018984", "3010493171", "1055236", "3010131137", "3010885402", "3009513193", "3036773433", "3007487007", "3015895145", "3016555232", "2183744", "1054241", "2320762", "3033307563", "3005369776", "3014279513", "3014579161", "2084346", "3010684280", "3012783431", "2125050", "3015153469" ], "fei_number": [ "3015895045", "2523865", "3010157088", "3005987240", "1000220650", "1718873", "1820334", "3015142721", "1220477", "3003968049", "3004215117", "1018470", "3007800906", "3043226252", "3013557562", "3012627460", "1000244733", "3007421149", "3016678045", "1450908", "3001451571", "3004491689", "3001238683", "3009719225", "3008439467", "3020331900", "3024860690", "3042940623", "1720929", "3032906574", "3013665681", "1450662", "1000138054", "3008770252", "3008254127", "3004727093", "1417485", "3013868968", "3013077751", "3016607092", "2528981", "3013283620", "3030447506", "1000112877", "3009328501", "1825146", "3004111573", "3014635169", "1000124817", "3012494290", "3015612252", "1627186", "3011063460", "3015224777", "3017619652", "2246552", "3016832577", "1625425", "1000115048", "3008571754", "3026606306", "3010041511", "3007345416", "3017820152", "1000117748", "3001611427", "3008367216", "3010701807", "1000112968", "1043214", "1047843", "1412854", "1000393132", "2916714", "3025325116", "3008309062", "1216677", "3014663814", "3002806816", "3001675293", "3018984", "3010493171", "3010131137", "3003058448", "3010885402", "3009513193", "3002806315", "3036773433", "3007487007", "3015895145", "3016555232", "2183744", "3033307563", "3005747797", "3001319476", "3005369776", "3014279513", "3014579161", "3000206455", "3010684280", "3012783431", "2125050", "3015153469", "3003040625" ], "device_name": "Cannula, Manipulator/Injector, Uterine", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4530", "device_class": "2" } } ] }