{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217379", "product_res_number": "Z-0908-2026", "event_date_initiated": "2025-11-06", "event_date_posted": "2025-12-11", "recall_status": "Open, Classified", "res_event_number": "97985", "product_code": "FAD", "k_numbers": [ "K043193" ], "product_description": "BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit\nREF 78826", "code_info": "Lot# NGJU4328/UDI: (01)00801741015922", "firm_fei_number": "1018233", "recalling_firm": "C.R. Bard Inc", "address_1": "8195 Industrial Blvd Ne", "city": "Covington", "state": "GA", "postal_code": "30014-1497", "additional_info_contact": "BD Medical Information Services\n1800-555-7422", "reason_for_recall": "Labeling discrepancy; Ureteral stent actual size may not match the actual product label.", "root_cause_description": "Under Investigation by firm", "action": "On Nov. 6, 2025, BD issued a \"Urgent Medical Device Recall\" Notification to consignees via regional courier service or e-mail. In addition to informing consignees about the recall, BD ask consignees to take the following actions: \n\n1. Immediately Discontinue Use.\n\n2. Please check all inventory locations within your institution for affected BD (C.R. Bard, Inc.) product listed in the Affected Product section below.\n\n3.Immediately quarantine and discard all devices within your facility s control per your facility s procedures.\n\n4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction).\n\n5.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product.\n\n6.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement )\n\n7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program", "product_quantity": "116 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).", "openfda": { "k_number": [ "K881744", "K213186", "K960148", "K905505", "K914280", "K982974", "K011264", "K163068", "K850176", "K170362", "K833782", "K832915", "K030503", "K941952", "K180469", "K013921", "K861478", "K163399", "K883561", "K830884", "K983498", "K250824", "K190312", "K161277", "K930882", "K190659", "K040760", "K021602", "K860055", "K871291", "K180029", "K141344", "K961371", "K872353", "K920695", "K251890", "K180057", "K873557", "K933941", "K200260", "K021140", "K974541", "K952513", "K190603", "K251469", "K232920", "K823487", "K173734", "K213444", "K882157", "K063742", "K925282", "K072293", "K201436", "K973504", "K981591", "K831857", "K865085", "K180216", "K875038", "K162104", "K162109", "K894357", "K834401", "K981491", "K863492", "K930733", "K903345", "K981489", "K850175", "K151051", "K852389", "K913928", "K243830", "K161236", "K213185", "K904231", "K243039", "K781641", "K171603", "K170422", "K191609", "K864225", "K880660", "K871667", "K840059", "K022447", "K864669", "K172017", "K800109", "K992391", "K860267", "K820870", "K923394", "K180053", "K172289", "K854908", "K854862", "K033210", "K211934", "K180557", "K961446", "K013784", "K851870", "K191446", "K010002", "K082805", "K212868", "K912060", "K930731", "K181971", "K991219", "K831446", "K160891", "K905289", "K170010", "K043193", "K946296", "K060673", "K031292", "K862539", "K910691" ], "device_name": "Stent, Ureteral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4620", "device_class": "2", "registration_number": [ "3009051888", "1424778", "1018233", "1000121056", "3014246639", "3010155661", "3005099803", "1225687", "3017210488", "3003790304", "3005987240", "3007156625", "3033589330", "3021632375", "1647149", "3012536737", "1313046", "1825146", "3005580113", "3011642792", "3030087693", "2124215", "3004365956", "2246552", "3015309643", "1048735", "3006082230", "1721504", "3009526575", "2027111", "3011050570", "3015225571", "3007695959", "3024807849", "2183744", "3010131137", "3012050423", "3006950086", "9681477", "3005232773", "1646831", "3009763019", "3013460719", "3013023255", "1828132", "3016096097", "9617744", "2125050", "3004859241", "3016678045", "3010273872", "3003915875", "3033848208", "1220477", "2030624", "9681442", "3002807314", "1123137", "9681260", "1037955", "2126666", "9611590", "2527072", "3008797804", "3012649202", "3001845648", "1000393132", "9610711", "1820334", "3003814961", "3005941719" ], "fei_number": [ "3009051888", "1018233", "1000121056", "3014246639", "3010155661", "3005099803", "3017210488", "3003790304", "3005987240", "3033589330", "3021632375", "1313046", "3012536737", "3001451463", "1825146", "3002806368", "3005580113", "3011642792", "3030087693", "2124215", "3004365956", "2246552", "3015309643", "3006279007", "3002807439", "1048735", "3006082230", "3009526575", "2027111", "1721504", "3011050570", "3015225571", "3007695959", "3002806565", "3003473227", "3024807849", "2183744", "3010131137", "3012050423", "3006950086", "1000306139", "3005232773", "1000160215", "3009763019", "3013460719", "3013023255", "1828132", "3016096097", "2125050", "3004859241", "3016678045", "3010273872", "3003915875", "3000206435", "3033848208", "1000123180", "1220477", "3002807314", "1037955", "2126666", "2527072", "3001845648", "3008797804", "3012649202", "3002807917", "1000393132", "3002807111", "3008133910", "1820334", "3003814961", "1000237915" ] } } ] }