{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221675", "product_res_number": "Z-2998-2026", "event_date_initiated": "2026-07-14", "event_date_posted": "2026-08-21", "recall_status": "Open, Classified", "res_event_number": "99497", "product_code": "GBM", "k_numbers": [ "K211436" ], "product_description": "Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: \n1) 82081 Ch08-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82081; \n2) 82101 Ch10-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82101; \n3) 82121 Ch12-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82121; \n4) 82141 Ch14-17 Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82141; \n5) 82084 Ch08 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82084; \n6) 82104 Ch10 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82104; \n7) 82124 Ch12 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82124; \n8) 82144 Ch14-40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82144; \n9) 82164 Ch16 40cm Onli Hydrophilic Urethral Intermittent Catheter, SKU/REF 82164; \n10) 85124 CH12 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85124; \n11) 85144 CH14 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85144; \n12) 85164 CH16 40cm Onli Coude Hydrophilic Urethral Intermittent Catheter, SKU/REF 85164.", "code_info": "SKU/REF 82081, UDI/DI 00610075072354, Lot Numbers: 5F273, 5F283, 5H293, 5J153, 6C313. \nSKU/REF 82101, UDI/DI 00610075072361, Lot Numbers: 5F283, 5G013, 5K253, 6A303. \nSKU/REF 82121, UDI/DI 00610075072385, Lot Numbers: 5H283, 5H293, 5K183, 5K193, 5K213, 6A253, 6A263, 6B053. \nSKU/REF 82141, UDI/DI 00610075072392, Lot Numbers: 5E063, 5E073, 5E083, 5F193, 5F203, 5F213, 5F223, 6B133. \nSKU/REF 82084, UDI/DI 00610075072408, Lot Numbers: 5E293, 5G213, 5G223, 6A223, 6A213. \nSKU/REF 82104, UDI/DI 00610075072415, Lot Numbers: 5E293, 5E303, 5G243, 5G253, 5J063, 5J073, 5L153, 6D203, 6E293. \nSKU/REF 82124, UDI/DI 00610075072422, Lot Numbers: 5E303, 5F033, 5F063, 5F043, 5F053, 5J223, 5J283, 5J243, 5K143, 6A163, 6A153, 6B173, 6B183, 5F073. \nSKU/REF 82144, UDI/DI 00610075072439, Lot Numbers: 6A163, 5F113, 5F133, 5I073, 5G083, 5E243, 5E253, 5E233, 5F103, 5I123, 5F143, 5E263, 5E273, 5I113, 5E283, 5F123, 5F153, 5G093, 5G183, 5G173, 5I153, 5I133, 5I143, 5I063, 6A173, 6B243, 5I103, 6B223, 6B233, 6B253, 6B263, 6B213, 6C033, 6C043, 6B273, 6C013, 6C023, 6C053, 6B283. \nSKU/REF 82164, UDI/DI 00610075072446, Lot Numbers: 6A223, 6B183, 5F153, 5F163, 5F183, 5F173, 5G103, 5G143, 5G113, 5G153, 6A233, 6C253, 6C243, 6C223, 6C233, 6D303, 6D293, 6D283. \nSKU/REF 85124, UDI/DI 00610075097432, Lot Numbers: 5K143, 5K133, 6B193. \nSKU/REF 85144, UDI/DI 00610075097449, Lot Numbers: 6B263, 6B273, 6C253, 5K133, 5K123, 5K113, 5K053, 5K043, 5K063, 5K073, 6A113, 6A133, 5K103, 6A123, 6A093, 6A103, 6C283, 6C263, 6C273, 6E013. \nSKU/REF 85164, UDI/DI 00610075097456, Lot Numbers: 6D303, 5K133, 6B193, 6A093, 6C283, 5L053, 5L043, 6A083, 5L193, 6A023, 5L223, 6A053, 6C293.", "firm_fei_number": "3005028195", "recalling_firm": "Hollister Ulc", "address_1": "Foxford Road REHINS", "city": "Ballina", "country": "Ireland", "additional_info_contact": "Tara Jankowski\n847-932-1996", "reason_for_recall": "Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding.", "root_cause_description": "Process control", "action": "Hollister issued an URGENT PRODUCT FIELD SAFETY NOTICE to its consignees on 7/16/2026 via USPS and email. The notice explained the issue, risk to health, and requested the consignee inspect each catheter for the potential presence of a protrusion (defect) located approximately 2 cm from the funnel. If a protrusion is identified, the catheter should not be used. Users should also review and follow the Instructions for Use (IFU) and ensure that the device is opened, handled, and inserted in accordance with the IFU. \nThe notice also requested the following actions be taken: \n\"Please follow the steps below:\n 1. Please complete and return the response form attached as soon as possible,\neven if you do not have product in your possession and send the form to\nComplaintCommunication@Hollister.com.\n 2. If you have supplied or transferred any potentially affected product to another\nfacility or organization, provide that facility with a copy of this letter immediately. \nFor further information or to request replacement devices please contact us:\nBy phone Please contact one of the following:\n If you are a consumer or healthcare professional, please call: 1.888.808.7456\n If you are a dealer, distributor, Institution, or pharmacy, please call: 1.800.323.4060 option 1\"", "product_quantity": "2526120 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K151772", "K193148", "K926369", "K180258", "K161672", "K160795", "K191512", "K892442", "K150935", "K760253", "K060268", "K101900", "K182511", "K965067", "K760254", "K943851", "K881667", "K191633", "K901336", "K072808", "K143594", "K050874", "K200142", "K241734", "K993651", "K143182", "K043241", "K011552", "K914905", "K031409", "K180801", "K200820", "K111405", "K183253", "K211436", "K181206", "K023254", "K830840", "K180070", "K090960", "K063795", "K012374", "K163179", "K941672", "K760093", "K020714", "K183461", "K961361", "K021938", "K973120", "K141642", "K192904", "K172278", "K901441", "K183335", "K190620", "K871999", "K952924", "K110862", "K121458", "K180824", "K213283", "K910876", "K142767", "K992137", "K121457", "K192468", "K192577", "K152268", "K970704", "K200134" ], "device_name": "Catheter, Urethral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2", "registration_number": [ "3008729910", "3007134520", "3008824097", "3011987967", "8040412", "3030671614", "3005778470", "3015176887", "3009732568", "3006536657", "9613662", "3008806809", "3006430057", "3022518300", "1820334", "3004111573", "1221765", "3007738736", "3013557562", "9616088", "8022978", "1828132", "3017961114", "3015142802", "3014404707", "9611004", "1480288", "9612030", "3014656749", "2029015", "8043792", "9611590", "3009337401", "1043214", "1055236", "9611712", "3005941719", "1932668", "3010288357", "9610694", "3016675012", "1423537", "3015131144", "1718873", "3033919393", "3016863553", "2124215", "3006082230", "3010400865", "3011137372", "9616668", "1000317571", "3006271008", "3005099803", "3006017180", "3006405073", "3008102042", "3011270181", "3010173425", "1417592", "3008191244", "1000121056", "3030678884", "2032112", "1054241", "2320762", "3010220595", "3020976354", "1061124", "2320961", "8040233", "3007185216", "3006371704", "1921846", "1018233", "9681260", "9680787", "1825146", "3006606901", "9710524", "1424263", "3011020307" ], "fei_number": [ "3008729910", "3007134520", "1000112968", "3008824097", "3002806565", "3011987967", "3030671614", "3005778470", "3015176887", "1000138417", "3009732568", "3006536657", "3002826093", "3003040625", "3008806809", "3006430057", "3022518300", "1820334", "3004111573", "3002807099", "1221765", "3003076831", "3002808269", "3007738736", "3005747797", "3013557562", "1828132", "3017961114", "3002919051", "3015142802", "3014404707", "1480288", "1000512168", "3002902735", "3014656749", "3003499455", "3006582718", "3009337401", "1043214", "3002924544", "3001236905", "3010288357", "3002807574", "3016675012", "1000160458", "3015131144", "1718873", "3033919393", "3016863553", "2124215", "3006082230", "3010400865", "1000317571", "3002806934", "3006271008", "3005099803", "3006017180", "3006405073", "3003172243", "3011270181", "1417592", "3008191244", "3002806731", "1000121056", "3030678884", "3003944071", "3009271244", "3010220595", "3020976354", "3002807036", "3003015552", "3007185216", "3002807111", "3006371704", "1921846", "1000237915", "1018233", "1825146", "1000112877", "3006606901", "3005028195", "3011020307" ] } } ] }