Esteem Body Soft Convex Urostomy Pouch Recall
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ConvaTec, Inc. is recalling 617,850 units of Esteem Body Soft Convex Urostomy Pouches due to potential leakage from the cap during use.
The full picture behind this FDA recall
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Urostomy Pouches may leak from cap during use.", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.
What Happened
ConvaTec, Inc. initiated a voluntary recall of certain Esteem Body Soft Convex Urostomy Pouches because the pouches may leak from the cap during use. The recall is classified as Class II by the FDA.
Which Products Are Affected
The affected products are Esteem Body Soft Convex Urostomy Pouch with model/catalog numbers 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727. A total of 617,850 units are involved. Distribution was nationwide in the United States, including 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. Specific lot codes are listed in the recall notice.
What You Should Do
Consumers should discontinue use of the affected products. Contact ConvaTec, Inc. for further instructions regarding returns or refunds.
Why This Matters
The recall affects over 617,000 units distributed nationwide and involves a potential leakage issue with urostomy pouches.
Source
FDA recall number Z-2986-2026
Original source: FDA Official Notice ↗
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Similar notices nationwide by length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,133 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Common Questions
Common questions about this FDA recall.