{"url_path":"/fda/device/recalls/Z-2986-2026","section_key":"summary","section_title":"DEVICE Recall: ConvaTec, Inc — Esteem Body Soft Convex Urostomy Pouch  Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2986-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ConvaTec, Inc"},"word_count":341,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2986-2026\n\n**Recalling firm:** ConvaTec, Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-06\n**Report date:** 2026-08-26\n\n## Product\nEsteem Body Soft Convex Urostomy Pouch  Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.\n\n## Reason\nUrostomy Pouches may leak from  cap during use.\n\n## Affected lots\nLot Code: Product Name : Esteem Body\" Urostomy Pouches   UDI-DI: 00768455204526, 00768455204533, 00768455204540, 00768455204564, 00768455204571, 00768455204588, 00768455204595,  00768455204618, 00768455204625, 00768455204632, 00768455204649, 00768455204656, 00768455204663, 00768455204670, 00768455204700, 00768455204717, 00768455204724, 00768455204748, 00768455204755, 00768455204762  Lot / 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 Lot / 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\n\n## Distribution\nUS 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."}