{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217710", "product_res_number": "Z-1061-2026", "event_date_initiated": "2025-11-29", "event_date_posted": "2026-01-12", "recall_status": "Open, Classified", "res_event_number": "98147", "product_code": "GBM", "k_numbers": [ "K192468" ], "product_description": "BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female\nREF: RTU14F", "code_info": "UDI: (01)06948796204063/Lot # T21823", "firm_fei_number": "3008729910", "recalling_firm": "HANGZHOU BEVER MEDICAL DEVICES CO., LTD.", "address_1": "Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street Building 2 No. 1-1 Houmuqiao Yongle Village Cangqian Street", "city": "Hangzhou", "country": "China", "additional_info_contact": "Mr. Allyson Zhou\n+8657188616630", "reason_for_recall": "Labeling error, Incorrect expiration date", "root_cause_description": "Labeling Change Control", "action": "On November 29, 2025, Hangzhou Bever Medical Devices issued a \"Medical Device Recall\" Notification via E-Mail. Hangzhou asked consignees to take the following actions: \n\n1) Immediately discontinue the distribution of the RTU14F product (Lot Number T21823), and isolate the products of this lot in inventory to avoid incorrect shipment or use.\n\n2)\nDiscard the affected devices in compliance with local, state, and federal medical waste regulations.\n\n3.If no alternative products are available currently, you may contact your sales representative to inquire about temporary alternative devices or solutions. \n\n4) After receiving this letter, please fill in the attached Recall Return Response Form, and return to us via email to confirm receipt of the recall notice.\n\n5) Forward the Customer Notification Letter and the Recall Return Response Form and to downstream customers, \n\n6) Handle all replacement requests from your downstream customers and coordinate the delivery of replacement units to your downstream customers once received from Bever.", "product_quantity": "149310 units", "distribution_pattern": "US Nationwide distribution in the state of GA.", "openfda": { "k_number": [ "K871999", "K881667", "K180801", "K101900", "K183461", "K760254", "K973120", "K941672", "K161672", "K180258", "K180824", "K926369", "K910876", "K141642", "K183253", "K191633", "K121458", "K163179", "K012374", "K151772", "K011552", "K181206", "K063795", "K830840", "K892442", "K183335", "K993651", "K192904", "K211436", "K180070", "K961361", "K200142", "K192468", "K970704", "K943851", "K200820", "K182511", "K050874", "K020714", "K143594", "K043241", "K190620", "K172278", "K090960", "K213283", "K952924", "K241734", "K760093", "K193148", "K901441", "K110862", "K150935", "K160795", "K965067", "K191512", "K031409", "K200134", "K760253", "K111405", "K021938", "K023254", "K914905", "K142767", "K192577", "K060268", "K072808", "K152268", "K901336", "K143182", "K121457", "K992137" ], "device_name": "Catheter, Urethral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2", "registration_number": [ "1825146", "1018233", "3010288357", "9710524", "3011987967", "3008191244", "3008824097", "3006371704", "3004111573", "9680787", "9611590", "3016675012", "9616668", "3015142802", "3006082230", "9616088", "1932668", "3017961114", "9611712", "3030671614", "3008729910", "2320762", "3009732568", "3007738736", "9681260", "2029015", "3020976354", "3011270181", "8040233", "3006536657", "1718873", "3009337401", "1221765", "8022978", "9613662", "3014656749", "9610694", "3011137372", "3007185216", "3010400865", "1828132", "9612030", "3008102042", "3007134520", "8043792", "3006430057", "3006405073", "3005778470", "1000121056", "1061124", "1055236", "3006271008", "8040412", "1423537", "3011020307", "3030678884", "1043214", "3005099803", "1000317571", "9611004", "2032112", "3016863553", "1054241", "1921846", "3022518300", "1424263", "3008806809", "1820334", "1480288", "3006017180", "3013557562", "2124215", "3033919393", "3010220595", "3015176887", "3015131144", "3006606901", "1417592", "3010173425", "3005941719", "3014404707", "2320961" ], "fei_number": [ "1825146", "1018233", "3010288357", "3011987967", "3008191244", "1000112877", "1000138417", "3008824097", "3002826093", "3006371704", "3004111573", "3016675012", "3002924544", "3015142802", "3006082230", "3017961114", "1000160458", "3030671614", "3008729910", "1000512168", "3009732568", "3007738736", "3020976354", "3011270181", "3006536657", "1718873", "3009337401", "3002806934", "1221765", "3003172243", "3014656749", "3002807036", "1000237915", "3002806565", "3003076831", "3007185216", "3005747797", "3005028195", "3010400865", "1828132", "3003499455", "3001236905", "3002902735", "3003015552", "1000112968", "3003944071", "3002808269", "3006582718", "3002806731", "3007134520", "3006430057", "3002807099", "3006405073", "3005778470", "3002807574", "1000121056", "3006271008", "3011020307", "3030678884", "1043214", "3002807111", "3009271244", "3005099803", "1000317571", "3016863553", "1921846", "3022518300", "3008806809", "1820334", "1480288", "3006017180", "3013557562", "2124215", "3033919393", "3010220595", "3003040625", "3015176887", "3015131144", "3006606901", "1417592", "3002919051", "3014404707" ] } } ] }