Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Esteem Synergy Stomahesive Skin Barrier Recalled by ConvaTec, Inc Due to Ostomy skin barrier package contains a pre-cut wafer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ConvaTec, Inc directly.
Affected Products
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
Quantity: 240
Why Was This Recalled?
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Where Was This Sold?
This product was distributed to 3 states: IL, NY, OH
About ConvaTec, Inc
ConvaTec, Inc has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report