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
Take action
Contact the company
📍Recalling firmConvaTec, Inc7815 National Service Rd Ste 600 · Greensboro, NC 27409-9403
“ConvaTec Esteem Synergy Stomahesive Skin Barrier Recall: Incorrect Wafer Size Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53378-convatec-esteem-synergy-stomahesive-skin-barrier-recall-incorrect-wafer-size. Based on FDA recall #Z-0903-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0903-2025%22&limit=1).
The FDA announced on November 29, 2024, that ConvaTec, Inc. is recalling Esteem Synergy Stomahesive Skin Barrier ostomy systems due to incorrect wafer sizes. The hazard involves pre-cut wafers being 28mm instead of the labeled 16mm or 35mm. This error can prevent use or cause abrasion and bleeding.
How to tell if you have it
Brand: ConvaTec
Product: Esteem Synergy Stomahesive Skin Barrier
Model/REF: 405473 (ESTEEM SYN FLX WHT16/35MM PRECUT(1X10))
Model/REF: 405479 (ESTEEM SYN FLX WHT35/35MM PRECUT(1X10))
Lot Codes: 3J03813, 3J03814
Distribution: OH, NY, IL
The hazard
The package contains a pre-cut wafer of 28mm instead of the labeled 16mm and/or 35mm. If the pre-cut wafers are too big, the device cannot be used. If the pre-cut wafer is too small and the user tries to apply it, this could cause abrasion, stomal cut, and bleeding.
Context
GovInfoNow's records show ConvaTec, Inc. has had 17 other recalls on record since October 26, 2017. Other recent recalls of similar products include ConvaTec Esteem Body Soft Urostomy Pouches (July 6, 2026), ConMed Suture Anchor (July 14, 2026), and ConvaTec Aquacel Ag Surgical SP Dressings (June 8, 2026).
How to tell if you have this one
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.
Brand
ConvaTec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the pre-cut wafer size on the label; the recalled products have 28mm instead of 16mm or 35mm.
Contact Manufacturer
Reach out to ConvaTec for guidance on the correct product or replacement options.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “US distribution to states of: OH, NY, IL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, New York, Ohio.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0903-2025 (November 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0903-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.