{ "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": 1 } }, "results": [ { "cfres_id": "214316", "product_res_number": "Z-2462-2025", "event_date_initiated": "2025-06-18", "event_date_posted": "2025-08-28", "recall_status": "Open, Classified", "res_event_number": "97041", "product_code": "EZL", "k_numbers": [ "K070582" ], "product_description": "Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; \nSureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A;\nBard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S;\nBard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S", "code_info": "Catalog/UDI-DI/Lot(Expiration):\n119314/00801741039843, 10801741039840/NGJS3588(31/03/2029), NGKQ2500(21/12/2029), NGKQ0170(30/11/2029), NGJW2499(31/08/2029), NGJT1284\t(31/03/2029), NGKQ2492(31/12/2029), NGKP3152(31/12/2029), NGJX0215(31/07/2029).\n\nA319514A/00801741100321, 10801741100328/NGJN0498(31/01/2026), NGJW3127(30/04/2027)\n\n29000J14/21200BZY00110000/MYJX0683(28/05/2027), MYJP0751(28/02/2027), MYJR1984(28/04/2027), MYJQ0070(28/04/2027), MYJS6278(28/04/2027), MYJR3026(28/04/2027), MYJT3766(28/04/2027), MYJY6197(28/06/2027), MYJX2833(28/06/2027), MYJQ4022(28/04/2027), MYJT3764(28/04/2027), MYJZ0962(28/06/2027), MYJS4679(28/04/2027), MYJX0686(28/06/2027), MYJV4359(28/03/2027), MYJS3597(28/04/2027), MYJW1900(28/04/2027), MYJT3765(28/04/2027), MYJY1245(28/06/2027), MYJY1242(28/06/2027), MYJY1248(28/06/2027).\n \n29030J14/21200BZY00110000/MYJX2846(28/06/2027), MYJP2013(28/02/2027), MYJT1017(28/04/2027), MYJW1906(28/04/2027), MYJT4535(28/07/2027), MYJP4407(28/04/2027), MYJS1895(28/04/2027), MYJW1904(28/04/2027), MYJV4102(28/03/2027), MYJX2836(28/05/2027), MYJZ4526(28/06/2027), MYJT3468(28/04/2027), MYJP2012(28/02/2027), MYJV4099(28/03/2027), MYJZ0964(28/06/2027), MYJQ0071(28/04/2027), MYJS6279(28/04/2027), MYJY4511(28/06/2027), MYJQ4024(28/04/2027), MYJZ0963(28/06/2027), MYJT1018(28/04/2027), MYJR3027(28/04/2027), MYJS3599(28/04/2027), MYJQ4023(28/04/2027), MYJR3083(28/04/2027), MYJY4512(28/06/2027), MYJQ0073(28/04/2027), MYJS1893(28/04/2027), MYJN2580(28/01/2027), MYJU2705(28/08/2027), MYJZ4527(28/06/2027), MYJS1894(28/04/2027), MYJV4103(28/03/2027), MYJR3059(28/04/2027), MYJU0772(28/08/2027), MYJV4101(28/03/2027), MYJY4513(28/06/2027), MYJQ0072(28/04/2027), MYJU3846(28/03/2027), MYJU3847(28/05/2027), MYJX2841(28/06/2027), MYJX2840(28/05/2027), MYJX2839(28/05/2027), MYJY4510(28/06/2027), MYJY4509(28/06/2027), MYJV4100(28/06/2027), MYJU3848(28/06/2027).\n\n29000J14S/21200BZY00110000/MYJY1249(28/06/2027), MYJY0937(28/05/2027), MYJW1903(28/03/2027).\n\n29030J14S/21200BZY00110000/MYJU0773(28/08/2027)", "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": "770-784-6100", "reason_for_recall": "Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.", "root_cause_description": "Process design", "action": "On 6/18/2025, recall notices were mailed or emailed to Recall Coordinators, Directors of Nursing, Purchasing, Risk Management, and distributors who were informed the following:\n\nThe affected product was distributed from 07 March 2024 to 14 May 2025.\n\n- If affected product is currently indwelling and draining urine appropriately, the catheter does not need to be removed. \n\n- For affected product currently not in use, quarantine, and dispose of unused product and source alternative product.\n\n- 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\n- If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product.\n\n- Complete and return the attached Customer Response Form via Email BDRC26@bd.com\n\nReport any complaints experienced with the use of this product to the firm via the North American Regional Complaint Center:\nPhone: 1-844-8BD-LIFE (1-844-823-5433) say \"Product Complaints\" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com\nFirm's Medical Information Services: 1-800-555-7422, medical.information@bd.com", "product_quantity": "175,158", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.", "openfda": { "k_number": [ "K961697", "K031748", "K030813", "K071423", "K030120", "K932809", "K013174", "K002612", "K902710", "K903777", "K980919", "K142635", "K972184", "K911617", "K130908", "K970716", "K262056", "K101824", "K982970", "K190060", "K944673", "K090262", "K810691", "K964757", "K233411", "K070582", "K173657", "K150550", "K003784", "K062112", "K894883", "K042709", "K052168", "K040504", "K201776", "K070508", "K232469", "K103371", "K173533", "K221020", "K954752", "K172422", "K260756", "K941488", "K921561", "K082919", "K091767", "K003289", "K930344", "K221625", "K240057", "K021142", "K964575", "K241424", "K173340", "K981612", "K951103", "K971643", "K944382", "K231101", "K944381", "K243011", "K971796", "K192034", "K944007", "K951106", "K041983", "K071049", "K023090", "K053429", "K181346", "K993063", "K941692", "K974419", "K091699", "K982626", "K181616", "K042110", "K990500", "K180781", "K780062", "K202698", "K200556", "K161770", "K131655", "K212077", "K990509", "K070558", "K024010", "K013172", "K934895", "K182463", "K110214", "K182635", "K905042", "K150699", "K922821", "K002868", "K153655", "K022287", "K021939", "K172807", "K063442", "K771860", "K222118", "K131020", "K944676", "K212151", "K091516", "K973076", "K140099", "K971801", "K233013", "K181814", "K945806", "K772218", "K944376", "K984084", "K010006", "K033830", "K980870", "K935630", "K051059", "K944380", "K202134", "K252537", "K082815", "K140667", "K162989", "K013276" ], "registration_number": [ "3005515211", "3006082230", "1423662", "3000268902", "3030446844", "3003903031", "3016738724", "3006787036", "1526534", "3015142802", "3001124136", "3029906222", "8043983", "3011252788", "3010580321", "3003477135", "3013002100", "3043051314", "9616567", "3011707784", "8040607", "3016904853", "3015337348", "3003537036", "9610711", "1721676", "1058397", "3030089838", "3013298431", "3012649202", "1058584", "3004111573", "3008959444", "3010400865", "9611590", "3038139564", "8041005", "3016998661", "3027553380", "1820334", "3014637079", "1825146", "3040153768", "3005483737", "3005609751", "3010621964", "3010173425", "3011383638", "2030624", "1921846", "3014650073", "3022516937", "3013557562", "3016618143", "3008806809", "3010131137", "3014656749", "3007798534", "3012833053", "3008559295", "3021468326", "2648727", "3014579161", "1928237", "3020978007", "3012421607", "3013369910", "3015173212", "2011171", "1055236", "3003814961", "3022518300", "3014766734", "3027301746", "2432320", "3009086335", "8040412", "3007156625", "1018233", "1650927", "1721686", "3000247873", "3004070478", "2320762", "3010220595", "1054241", "3005941719", "3010314836", "3030970103", "8022978", "1314417", "3011137372", "3012104670", "3027547323", "3031190571", "1417592", "3008502431", "3002907620", "1061124", "3005669815", "2029015", "3000308637", "3031175043", "1423537", "3005012805", "3012050423", "2032112", "9616088", "3011987967", "1649518", "3015997711", "3003965134", "3006621386", "3000247987", "3008496528", "9612030", "1043214", "3015176887", "9611712", "8030107" ], "fei_number": [ "1000512168", "3005515211", "3016261803", "3006082230", "3000268902", "3030446844", "3002806591", "1000521377", "1000160458", "3003903031", "3016738724", "3006787036", "1526534", "3015142802", "3001124136", "3029906222", "3011252788", "3005747797", "3010580321", "3003477135", "3013002100", "3043051314", "3011707784", "3016904853", "3015337348", "3003537036", "1721676", "3030089838", "3013298431", "3012649202", "3004111573", "3008959444", "3010400865", "3038139564", "3016998661", "1000112877", "3027553380", "3002806934", "1000219637", "1820334", "3014637079", "1825146", "3040153768", "3005483737", "3005609751", "1000112968", "3008133910", "3010621964", "1000237915", "3011383638", "1921846", "3014650073", "3002695476", "3002807574", "3022516937", "3013557562", "3016618143", "3003076831", "3008806809", "3010131137", "3014656749", "3007798534", "3001236277", "3012833053", "3006582718", "3003040625", "3008559295", "3021468326", "2648727", "3014579161", "1928237", "3020978007", "3012421607", "3001236905", "3013369910", "3015173212", "2011171", "3003814961", "3022518300", "3014766734", "3027301746", "3002807111", "7682", "3000206435", "3009086335", "1000158532", "1018233", "1721686", "3000247873", "3004070478", "3010220595", "3010314836", "3030970103", "1314417", "3009271244", "3000215273", "3012104670", "3027547323", "3031190571", "1417592", "3008502431", "3002907620", "3005669815", "3000308637", "3031175043", "3005012805", "3002963732", "3002807917", "3002902735", "3012050423", "3002807036", "3011987967", "3015997711", "3003965134", "3006621386", "3000247987", "3008496528", "1043214", "3002808507", "3015176887" ], "device_name": "Catheter, Retention Type, Balloon", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2" } } ] }