{ "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": "221624", "product_res_number": "Z-2986-2026", "event_date_initiated": "2026-07-06", "event_date_posted": "2026-08-19", "recall_status": "Open, Classified", "res_event_number": "99457", "product_code": "EXG", "product_description": "Esteem Body Soft Convex Urostomy Pouch\nModel/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.", "code_info": "Lot Code: Product Name : Esteem Body\" Urostomy Pouches\n\n UDI-DI: 00768455204526, 00768455204533, 00768455204540, 00768455204564, 00768455204571, 00768455204588, 00768455204595, 00768455204618, 00768455204625, 00768455204632, 00768455204649, 00768455204656, 00768455204663, 00768455204670, 00768455204700, 00768455204717, 00768455204724, 00768455204748, 00768455204755, 00768455204762\n\nLot / Serial Numbers for US market : 5H0475, 5J00257, 5J00475, 5J02234, 5J02340, 5J02361, 5J02732, 5K00013, 5K00338, 5K00713, 5K00338, 5K00713, 5K01320, 5K01500, 5K01541, 5K02079, 5K02104, 5K03003, 5K03008, 5L00231, 5L00444, 5L01041, 5L01042, 5L01162, 5L01935, 5L04677, 5L04679, 6A00067, 6A00218, 6A00219, 6¿01521, 6A01717 and 6A01964\nLot / Serial Numbers for global : 5J00020 , 5H04775 , 5J00257 , 5J00475 , 5J00476 , 5J00904 , 5J01425 , 5J01426 , 5J01512 , 5J01903 , 5J02218 , 5J02235 , 5J02340 , 5J02234 , 5J00903 , 5J02361 , 5J02362 , 5J01970 , 5J02732 , 5J04994 , 5J04995 , 5J05281 , 5K00712 , 5K00013 , 5K01500 , 5K01541 , 5K02080 , 5J05497 , 5K01320 , 5K02079 , 5K03003 , 5K00012 , 5K03008 , 5K01321 , 5K00338 , 5K03004 , 5K00713 , 5K02104 , 5K02095 , 5K06011 , 5K06313 , 5L00050 , 5L00231 , 5L00444 , 5K06686 , 5L00445 , 5L00691 , 5L01041 , 5L01042 , 5L01162 , 5L01508 , 5L01935 , 5L02306 , 5L02524 , 5L02796 , 5L03300 , 5L00948 , 5L04679 , 5L04677 , 5L05414 , 5L05415 , 6A00216 , 6A00217 , 6A00219 , 6A01188 , 6A00218 , 6A01717 , 6A01189 , 6A01521 , 6A00067 , 6A01522 , 6A01962 , 6A01964 , 6A01967 , 6A01965 , 6A01966 , 6A01963 , 6A02696", "firm_fei_number": "3011987967", "recalling_firm": "ConvaTec, Inc", "address_1": "7815 National Service Rd Ste 600 7815 National Service Rd", "address_2": "Ste 600", "city": "Greensboro", "state": "NC", "postal_code": "27409-9403", "additional_info_contact": "Media Relations\n336-547-3730", "reason_for_recall": "Urostomy Pouches may leak from cap during use.", "root_cause_description": "Material/Component Contamination", "action": "On July 20, 2026 Convatec issued a Urgent Medical Device Recall notification to affected consignees via Email. Convatec asked consignees to take the following actions:\n\n1. Examine your inventory and identify all affected product lots using the lot numbers provided in the communication. \n\n2a. (end-user) If you identify affected product, discontinue use of the affected device and contact your supplier, healthcare provider, or Convatec representative to obtain replacement product as soon as possible.\n\nIf replacement product is not immediately available and continued use is necessary, follow the interim precautionary instructions.\n\n2b. (distributor) Immediately quarantine and discontinue distribution, sale, transfer, and use of all affected product to prevent further distribution or use.\n\n3. Inform all appropriate personnel within your organization.\n\n4.If you have further distributed, transferred, or supplied any affected product, you must immediately notify all consignees and customers who may have received the affected product. Provide them with a copy of this recall notification and instruct them to take the actions described in this notice.\n\n5. Please confirm receipt of this notice and your compliance with the required actions by completing and returning the enclosed acknowledgement form to us.customerservice@CONVATEC.COM no later than by August 07, 2026.", "product_quantity": "617850 units", "distribution_pattern": "US Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.", "openfda": { "device_name": "Bag, Urine Collecting, Ureterostomy", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5900", "device_class": "1", "registration_number": [ "3003767891", "3013683058", "3044150131", "3008244559", "3015140199", "3013530949", "3005327291", "3014662855", "3013550220", "3023339256", "3013557562", "3013530901", "9618003", "3031582434", "3009167225", "1066607", "3011987967", "3013576541", "2320961", "3007417132", "3012421607", "3044921221", "3019865496", "3026818268", "3014437893", "3003965134", "3022120070", "1480288", "3023809973", "3011689956", "1047843", "9616668", "1000317571", "9680411", "3022596459", "9710020", "3003759552", "3013684380", "1119193", "9616083", "1520020", "3005078659", "1314417", "3008806809", "3034602341", "3010131137", "3005273623", "3045058049", "1825146", "3033858895", "2183564", "2530957", "1820334", "3011495142", "3015140210", "3015821396", "3017448136", "3006897996" ], "fei_number": [ "3003767891", "3013683058", "3044150131", "3008244559", "3015140199", "3013530949", "3005327291", "3014662855", "3013550220", "3003340795", "3023339256", "3013557562", "3013530901", "3031582434", "3009167225", "3011987967", "3013576541", "3044921221", "3007417132", "3012421607", "3019865496", "3026818268", "3014437893", "3003965134", "3022120070", "1480288", "1000522686", "3023809973", "3011689956", "1047843", "1000317571", "3022596459", "3003759552", "3013684380", "1119193", "1520020", "3003282547", "3005078659", "1000612470", "1314417", "3003264198", "3003172243", "3008205331", "3008806809", "3034602341", "3010131137", "3005273623", "3045058049", "1825146", "3033858895", "2183564", "3005028195", "1820334", "3011495142", "3015140210", "3015821396", "3017448136", "3006897996" ] } } ] }