{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "214248", "product_res_number": "Z-2135-2025", "event_date_initiated": "2025-06-11", "event_date_posted": "2025-07-18", "recall_status": "Open, Classified", "res_event_number": "97028", "product_code": "HIB", "k_numbers": [ "K920803" ], "product_description": "HSG Procedure Tray. Model Number: 6050T. \n\nThe HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.", "code_info": "Model Number: 6050T. UDI-DI 60888937003262. Lot Numbers: 339331, 339327, 339333, 339334, 343007.", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "Karen Gienau\n001-203-4054510", "reason_for_recall": "The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.", "root_cause_description": "Under Investigation by firm", "action": "CooperSurgical notified consignees on about 06/11/2025 via letter sent through certified mail. Specifically, consignees that are physicians or medical facilities were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. \n\nDistributors were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. They were also instructed to notify customers if the product was further distributed.", "product_quantity": "171 units", "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.", "openfda": { "k_number": [ "K120743", "K012859", "K022948", "K072762", "K020726", "K030761", "K252208", "K000414", "K020959", "K822086", "K052314", "K092870", "K974228", "K002912", "K003540", "K040817", "K130046", "K992736", "K933521", "K133857", "K880586", "K061339", "K060129", "K072942", "K052912", "K971979", "K963377", "K841909", "K880588", "K830725", "K880587", "K926536", "K012535", "K841867", "K941272", "K973853", "K863275", "K091937", "K000444", "K070964", "K863274", "K021017", "K842014", "K951528", "K882605", "K920803", "K930954", "K922154", "K042950", "K894489", "K951898", "K903080", "K132668", "K894957", "K021849", "K030693", "K935636", "K991827", "K822084", "K903744", "K013835", "K983716", "K991963", "K984211", "K925501", "K021676", "K052420", "K052192", "K050887", "K110766", "K013817", "K041757" ], "registration_number": [ "3010155661", "3005515211", "3016758972", "3006087789", "3000268902", "3011689956", "3012944064", "3031184338", "3022120070", "3004530184", "3006787036", "3009328501", "1836161", "3001124136", "3014610488", "3043226252", "3005739529", "3018779125", "3041276591", "3045058049", "3015134755", "3008902714", "3016250458", "2435946", "3038772401", "3016904853", "3015142721", "3008496560", "3013298431", "1319480", "3012292909", "8044093", "3004111573", "3011669217", "3013517171", "3004519921", "1319639", "2434982", "3012303525", "3018762668", "3014637079", "3034629649", "3009104075", "1835058", "3032109", "3015895045", "3018503755", "3006673317", "3004941127", "1450908", "9680222", "3012551896", "3006591312", "3017367014", "3014902417", "1316463", "3014437893", "3013557562", "8030607", "3016884033", "3016884191", "3015276780", "8043235", "3006410968", "2027062", "3007789561", "1018470", "3006538822", "3015058854", "3033536319", "9613910", "3014579161", "3024374351", "3034669683", "3012421607", "2648727", "3019387954", "3015173212", "3012494290", "1055236", "2431166", "3045323835", "3009771213", "3009308092", "3016195240", "3014421917", "3030733800", "2320762", "1054241", "3038285060", "1123010", "3030626857", "3005273623", "3032747418", "3000682787", "3009255580", "1417592", "1315756", "3004488394", "1061124", "3005669815", "3006897996", "1317202", "3013530901", "1423537", "3003528228", "3037918935", "3010830834", "3010419931", "3003431869", "3019315696", "1216677", "3015416207", "9616088", "3003965134", "3016159368", "1043214", "3030447506", "3004472854" ], "fei_number": [ "3001238683", "3010155661", "1000512168", "3005515211", "3003154916", "3016758972", "3006087789", "3000268902", "3011689956", "3012944064", "3031184338", "3022120070", "3004530184", "3006787036", "3009328501", "3001124136", "3006509795", "3014610488", "3043226252", "3005739529", "3018779125", "3041276591", "3045058049", "3015134755", "3008902714", "3016250458", "3038772401", "3016904853", "3015142721", "3008496560", "3013298431", "3012292909", "3004111573", "3011669217", "3013517171", "1000112877", "2434982", "3012303525", "3018762668", "3014637079", "3034629649", "1000137528", "3009104075", "1000123297", "3015895045", "3018503755", "1000112968", "3004941127", "1450908", "3012551896", "3006591312", "3017367014", "3014902417", "3005729015", "1316463", "2523865", "1000120295", "3014437893", "3013557562", "3016884033", "3016884191", "3015276780", "3006410968", "2027062", "3007789561", "3003040625", "1018470", "3006538822", "3005846326", "1000517814", "3015058854", "3033536319", "3004525092", "3014579161", "3024374351", "3034669683", "3012421607", "2648727", "3001236905", "3019387954", "3015173212", "3012494290", "1000138054", "3045323835", "3009771213", "3009308092", "3016195240", "3014421917", "3030733800", "3038285060", "3030626857", "3005273623", "2981", "3004574120", "3032747418", "3000682787", "3009255580", "1417592", "1315756", "3004488394", "3005669815", "3006897996", "1317202", "3013530901", "3037918935", "3003528228", "3010419931", "3002750084", "3005596530", "3003431869", "3002902735", "3019315696", "1216677", "3015416207", "3003965134", "3016159368", "1043214", "3030447506", "3004472854" ], "device_name": "Speculum, Vaginal, Nonmetal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.4530", "device_class": "2" } } ] }