Recall Z-2986-2026— ConvaTec, Inc

Class II · Ongoing

Class II FDA medical device recall by ConvaTec, Inc, initiated 2026-07-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Urostomy Pouches may leak from cap during use..

Recalling firm
ConvaTec, Inc
Classification
Class II
Status
Ongoing
Initiated
2026-07-06
Firm location
Greensboro, NC, United States

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.

Reason for recall

Urostomy Pouches may leak from cap during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.