ConvaTec recalls Esteem Synergy Stomahesive Skin Barrier products with incorrect pre-cut wafer sizes (16mm or 35mm) that could cause abrasion, stomal cuts, or bleeding if used improperly.
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
ConvaTec is recalling Esteem Synergy Stomahesive Skin Barrier products that have pre-cut wafers of the wrong size (28mm instead of 16mm or 35mm). Using these incorrect sizes could cause skin abrasion, stomal cuts, or bleeding during ostomy care.
The recalled products have pre-cut wafers that are 28mm instead of the correct 16mm or 35mm sizes. If the wafer is too large, the device cannot be used properly. If too small, applying it could cause skin abrasion, stomal cuts, or bleeding.
People using ConvaTec's Esteem Synergy Stomahesive Skin Barrier for ostomy care are affected. Those with ostomies who use the recalled products are at risk of skin injury.
Check the product label for the pre-cut wafer size: 28mm instead of 16mm or 35mm. The affected products include ESTEEM SYN FLX WHT16/35MM PRECUT(1X10) with reference number 405473 and ESTEEM SYN FLX WHT35/35MM PRECUT(1X10) with reference number 405479.
Look for the pre-cut wafer size on the label; the recalled products have 28mm instead of 16mm or 35mm.
Reach out to ConvaTec for guidance on the correct product or replacement options.
The recalled products have pre-cut wafers that are 28mm instead of the correct 16mm or 35mm sizes, which could cause skin abrasion, stomal cuts, or bleeding if used improperly.
Check the product label for the pre-cut wafer size; if it's 28mm instead of 16mm or 35mm, contact ConvaTec for guidance on the correct product or replacement options.
Yes, the affected products include ESTEEM SYN FLX WHT16/35MM PRECUT(1X10) with reference number 405473 and ESTEEM SYN FLX WHT35/35MM PRECUT(1X10) with reference number 405479.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-0903-2025 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-0903-2025 from ConvaTec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
