ESTEEM recallZ-2986-2026 · ConvaTec, Inc · initiated Jul 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Urostomy Pouches may leak from cap during use.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-2986-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 6, 2026
- Posted by the FDA
- Aug 19, 2026
- Recalling firm
- ConvaTec, Inc
- Quantity
- 617850 units
- Product code
- EXG
- 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 description
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.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- ESTEEM 423727Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall1 report
- ESTEEM 423704Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423705Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423712Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423713Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423714Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423715Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423716Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423717Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423718Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423722Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423723Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423725Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
- ESTEEM 423726Convatec, Purchasing Department · BAG, URINARY, ILEOSTOMY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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