{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219556", "product_res_number": "Z-2226-2026", "event_date_initiated": "2026-04-23", "event_date_posted": "2026-05-21", "recall_status": "Open, Classified", "res_event_number": "98716", "product_code": "EZL", "k_numbers": [ "K951103" ], "product_description": "Silastic Foley Catheters\nSilastic Brand Foley Catheter 30cc\nREF:\n33416\n33418\n33420\n33422\n33424\n\nSilastic Brand Foley Catheter 5cc\nREF:\n33614\n33616\n33618\n33620\n33622\n33624", "code_info": "Silastic Brand Foley Catheter 30cc\nCatalog Number / UDI code:\n33416 / 00801741019982\t10801741019989\nLot Number: NGKX0444\n\n33418 / 00801741019999\t10801741019996\nLot Number: NGKW2813\n\n33420 / 00801741020001\t10801741020008\nLot Number: NGKQ1015\n\n33422 / 00801741020018\t10801741020015\nLot Number: NGKW3707\n\n33424 / 00801741020025\t10801741020022\nLot Number: NGKW2669\n\n\nSilastic Brand Foley Catheter 5cc\nCatalog Number / UDI code:\n33614 / 00801741020056\t10801741020053\nLot Numbers:\nNGKN4037\nNGKP1420\nNGKQ0040\nNGKQ3901\nNGKS4937\nNGKV3462\nNGKW3897\n\n33616 / 00801741020063\t10801741020060\nLot Numbers:\nNGKQ0042\nNGKQ3946\nNGKR3420\nNGKT3281\nNGKU1015\nNGKV0617\nNGKV2275\nNGKV2309\nNGKW3771\n\n33618 / 00801741020070\t10801741020077\nLot Numbers:\nNGKQ3370\nNGKS3753\nNGKT3258\nNGKT3309\nNGKU4129\nNGKV1446\nNGKV2345\nNGKV3478\nNGKV5029\n\n33620 / 00801741020087\t10801741020084\nLot Numbers:\nNGKS5060\nNGKT3308\nNGKV3689\n\n33622 / 00801741020094\t10801741020091\nLot Numbers:\nNGKQ1016\nNGKS0244\nNGKU0967\nNGKV5075\nNGKX0441\n\n33624 / 00801741020100\t10801741020107\nLot Numbers:\nNGKQ1722\nNGKQ3862\nNGKT3259\nNGKX0456", "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": "Mark Tremblay\n678-230-2787", "reason_for_recall": "Due to stain present on the surface of affected foley catheters.", "root_cause_description": "Material/Component Contamination", "action": "On 04/23/2026, the firm sent via region courier services \"URGENT Medical Device Recall\" Letters informing customers that BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected silastic catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter.\n\nCustomers are instructed to:\n1. Immediately Discontinue Use\n2. Please check all inventory locations within your institution for the Bard Silastic Foley Catheters listed in Attachment 2.\n3. Immediately quarantine and destroy all devices within your facility s control per your facility s procedures.\n4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction.\n5. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit.\n6. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit.\n\nFor Questions:\nProduct Use Inquiries - 1-800-555-7422 option #2 available 24hours/7 days per week\nProduct Complaints, Technical Support - 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: productcomplaints@bd.com", "product_quantity": "106,160", "distribution_pattern": "U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI\n\nO.U.S.: Canada", "openfda": { "k_number": [ "K212151", "K021939", "K130908", "K040504", "K091767", "K971643", "K771860", "K930344", "K181814", "K972184", "K973076", "K240057", "K182635", "K071423", "K181616", "K192034", "K182463", "K013174", "K974419", "K905042", "K031748", "K190060", "K232469", "K810691", "K013172", "K070508", "K082815", "K262056", "K780062", "K944673", "K961697", "K002868", "K233411", "K951106", "K030813", "K980870", "K053429", "K172422", "K180781", "K233013", "K964757", "K221020", "K062112", "K010006", "K101824", "K222118", "K241424", "K070582", "K033830", "K003784", "K911617", "K903777", "K944381", "K150699", "K091699", "K110214", "K980919", "K173533", "K993063", "K922821", "K173657", "K071049", "K201776", "K013276", "K051059", "K142635", "K934895", "K944380", "K082919", "K941692", "K951103", "K070558", "K042709", "K131655", "K161770", "K944676", "K935630", "K041983", "K252537", "K221625", "K970716", "K964575", "K042110", "K172807", "K091516", "K131020", "K982970", "K024010", "K030120", "K902710", "K140099", "K162989", "K181346", "K772218", "K103371", "K173340", "K200556", "K971796", "K982626", "K932809", "K090262", "K150550", "K003289", "K202698", "K945806", "K990509", "K202134", "K894883", "K944376", "K243011", "K990500", "K921561", "K944382", "K153655", "K063442", "K002612", "K023090", "K971801", "K022287", "K941488", "K212077", "K231101", "K954752", "K140667", "K944007", "K052168", "K021142", "K981612", "K984084" ], "device_name": "Catheter, Retention Type, Balloon", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2", "registration_number": [ "3008806809", "9612030", "3013557562", "8040607", "1061124", "8030107", "1820334", "3005012805", "3008959444", "8041005", "3012833053", "3004070478", "3015142802", "9616088", "3012050423", "1721686", "3022518300", "3012421607", "3014637079", "1650927", "3003814961", "1018233", "3005941719", "1058584", "3010580321", "3011252788", "3011137372", "3013298431", "1043214", "3030089838", "1423537", "3016738724", "8043983", "3021468326", "3000308637", "3003903031", "3010400865", "3009086335", "3027547323", "3006621386", "3002907620", "9611712", "1055236", "3027301746", "1825146", "3003965134", "3003477135", "9611590", "2032112", "3038139564", "3008502431", "3001124136", "3014579161", "3006082230", "3012649202", "2432320", "3000268902", "3020978007", "2648727", "8022978", "3030970103", "1054241", "3000247873", "3005515211", "3007156625", "3010131137", "3010173425", "3012104670", "3011987967", "3040153768", "1526534", "1423662", "1058397", "3015337348", "3006787036", "3005609751", "3022516937", "3005483737", "3008496528", "1314417", "3007798534", "3011707784", "2029015", "3003537036", "3010220595", "3014766734", "1928237", "3031175043", "1921846", "3015176887", "3016998661", "2030624", "3043051314", "8040412", "3015997711", "3005669815", "3013002100", "3013369910", "3014650073", "3016904853", "1417592", "9616567", "2320762", "3004111573", "3010314836", "3016618143", "3031190571", "1649518", "3008559295", "3010621964", "3029906222", "9610711", "1721676", "3015173212", "3000247987", "3027553380", "3011383638", "2011171", "3014656749" ], "fei_number": [ "3008806809", "3013557562", "1820334", "3005012805", "1000112877", "3002808507", "3002963732", "3008959444", "3012833053", "3004070478", "3015142802", "3012050423", "1721686", "3022518300", "3012421607", "3014637079", "3001236905", "3003814961", "1018233", "3002807111", "1000512168", "3010580321", "3011252788", "3002807036", "3003040625", "3013298431", "1043214", "3030089838", "3016738724", "3021468326", "3000308637", "3003903031", "3010400865", "3009086335", "3027547323", "3006621386", "3002907620", "3027301746", "1825146", "3003965134", "3003477135", "3038139564", "3008502431", "3001124136", "3014579161", "3006082230", "3012649202", "3000268902", "3020978007", "2648727", "3002806934", "3000206435", "3030970103", "3000247873", "3005515211", "3010131137", "3005747797", "3012104670", "3011987967", "1000219637", "1000237915", "3040153768", "1526534", "1000158532", "7682", "3015337348", "3006787036", "3005609751", "3002695476", "3022516937", "3005483737", "3008496528", "1000160458", "1314417", "3007798534", "3011707784", "3003537036", "3010220595", "3001236277", "3014766734", "3002806591", "1928237", "3031175043", "1921846", "3015176887", "3016998661", "3006582718", "3043051314", "3008133910", "3002807574", "3015997711", "1000112968", "3005669815", "3013002100", "3013369910", "3014650073", "3016904853", "1417592", "3016261803", "3000215273", "3004111573", "3010314836", "3016618143", "3031190571", "3008559295", "3010621964", "3029906222", "3002807917", "1721676", "3015173212", "3009271244", "3000247987", "3027553380", "3003076831", "1000521377", "3011383638", "2011171", "3014656749", "3002902735" ] } } ] }