{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222788", "product_res_number": "Z-0163-2027", "event_date_initiated": "2026-09-16", "event_date_posted": "2026-10-15", "recall_status": "Open, Classified", "res_event_number": "99875", "product_code": "FBK", "k_numbers": [ "K171602" ], "product_description": "Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112", "code_info": "UDI-DI: 00827002161122;\nLot Numbers: 16613606, 16951548, 16951548X", "firm_fei_number": "1820334", "recalling_firm": "Cook Incorporated", "address_1": "750 N Daniels Way", "city": "Bloomington", "state": "IN", "postal_code": "47404-9120", "additional_info_contact": "Cook Medical Customer Relations Department\n812-339-2235", "reason_for_recall": "The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/16/26 was sent to customers.\n\nActions to be Taken by the Customer\n1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products.\n2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions.\n3. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com).\n4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred.\n5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.\nAction being Taken by Cook Medical\nCook Medical is removing potentially affected products from the market. Additionally, an investigation has been opened to determine the appropriate actions to prevent reoccurrence of a similar issue.\nIf you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.", "product_quantity": "97 units", "distribution_pattern": "US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.", "openfda": { "k_number": [ "K953441", "K181690", "K903668", "K221085", "K894868", "K151475", "K050688", "K213914", "K851952", "K232826", "K941305", "K954519", "K253598", "K000646", "K953338", "K090830", "K190829", "K002778", "K152035", "K982890", "K001146", "K812057", "K180214", "K031238", "K232200", "K260262", "K961846", "K011484", "K902736", "K924102", "K172227", "K092090", "K252021", "K914496", "K132065", "K834403", "K990996", "K190032", "K213239", "K901437", "K113634", "K210917", "K865086", "K091391", "K240675", "K133148", "K171454", "K222006", "K883093", "K002323", "K220292", "K111495", "K002573", "K950976", "K983765", "K051905", "K192498", "K232442", "K212668", "K090217", "K960519", "K855176", "K121337", "K241595", "K896424", "K921800", "K043383", "K241523", "K030451", "K042615", "K150434", "K061222", "K022484", "K951648", "K955558", "K012977", "K230925", "K153625", "K872060", "K010448", "K221054", "K820973", "K933815", "K252247", "K142144", "K013712", "K082319", "K042882", "K171602" ], "registration_number": [ "9681260", "3008573567", "3012042439", "1721676", "2183446", "2020550", "2246552", "3013526170", "3015142721", "1047843", "3010707607", "3014769442", "3012649202", "9614641", "2431166", "3012480535", "3011193403", "3014342096", "9610617", "1825146", "3006750742", "1722746", "3011707784", "3015972753", "3015895045", "3008274780", "3013460719", "3010419931", "1647149", "9680001", "3005580113", "3030447506", "3010288205", "3010202439", "3009888344", "1061927", "1000121056", "3035451914", "3002647932", "3021023752", "3005987240", "3008797804", "2134494", "3009064553", "1000393132", "3011050570", "3046205723", "8010047", "3017390965", "1220592", "3004083736", "9680809", "3010273872", "1056129", "3008040402", "3014620201", "1643817", "3027454635", "1828424", "3009747810", "3011146996", "9610711", "3007695959", "3005941719", "1528319", "3017178358", "3017448360", "3006621103", "3021632375", "3025311469", "1037905", "3004837686", "1222168", "3018116884", "3004129994", "1820334", "3004784537", "3007156625", "3008693678", "1519132", "3007699067", "3013023255", "3010188783", "3017262662", "3004207966", "3035434483", "3013440400", "9610614", "3005099803", "1018233", "3041276591", "3043141270", "3003814961", "3010515547", "3027269340", "3008048800", "3011270181", "3000279801", "3015042209" ], "fei_number": [ "3008573567", "3012042439", "1721676", "2183446", "2020550", "2246552", "3013526170", "3015142721", "3002995060", "1047843", "3010707607", "3008133910", "3014769442", "3012649202", "3012480535", "3011193403", "3014342096", "1825146", "3006750742", "3011707784", "3015972753", "3015895045", "3008274780", "3013460719", "3010419931", "3002619738", "3005580113", "3030447506", "3010288205", "3002807917", "3009888344", "1000121056", "3035451914", "3002647932", "3021023752", "1000132436", "3005987240", "3008797804", "3009064553", "3002807111", "1000393132", "3003995201", "3002806565", "3011050570", "3046205723", "1000122656", "2523865", "3002808268", "3017390965", "1220592", "3002807795", "3004083736", "3010273872", "3008040402", "3002808445", "1000306139", "3014620201", "1643817", "3027454635", "1828424", "3009747810", "3011146996", "3007695959", "3007475226", "3017178358", "3017448360", "3006621103", "3021632375", "3025311469", "1037905", "3004837686", "3000203000", "1222168", "3018116884", "3004129994", "1820334", "1000306216", "3004784537", "3008693678", "1519132", "3007699067", "3002806920", "3013023255", "3010188783", "3017262662", "3004207966", "3035434483", "3013440400", "3005099803", "1018233", "3041276591", "3043141270", "3003814961", "3010515547", "3027269340", "3008048800", "3011270181", "3000279801", "3015042209" ], "device_name": "Endoscopic Injection Needle, Gastroenterology-Urology", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }