Z-2986-2026Class II

Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709...

Name: Z-2986-2026 Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709...
Creator: ConvaTec, Inc
Published: 2026-07-06
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2026-07-06 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716... on 2026-07-06. FDA classified it as Class II and gives the reason as "Urostomy Pouches may leak from cap during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2986-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-06
Posted: 2026-08-19
Recalling firm: ConvaTec Limited
Product: 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.
Product code: EXG Bag, Urine Collecting, Ureterostomy
Reason for recall: Urostomy Pouches may leak from cap during use.
Root cause tag: manufacturing process
FDA root cause: 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: 1. Examine your inventory and identify all affected product lots using the lot numbers provided in the communication. 2a. (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. If replacement product is not immediately available and continued use is necessary, follow the interim precautionary instructions. 2b. (distributor) Immediately quarantine and discontinue distribution, sale, transfer, and use of all affected product to prevent further distribution or use. 3. Inform all appropriate personnel within your organization. 4.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. 5. Please confirm receipt of this notice and your compliance with the required actions by completing and returning the enclosed acknowledgement form to [email protected] no later than by August 07, 2026.
Quantity in commerce: 617850 units
Distribution: 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.
Product codes and lots: Lot 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2986-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2986-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-19

Product code EXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)