Convatec Esteem Synergy Stomahesive Skin Barrier Recalled for Size Defect
ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a dimensional labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConvaTec, Inc. is recalling 200 boxes of 10 units of Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475. The product is a precut skin barrier used with Esteem Synergy pouches to manage stomal output. The recall involves Lot Number 7F00987, which was distributed nationwide in the United States.
The recall was initiated because it was discovered that the stoma hole of the skin barrier wafers in this specific lot is larger than the 7/8 inch / 22mm size specified on the box label. This dimensional discrepancy may affect the fit of the ostomy system.
Consumers who have this product should stop using it and contact ConvaTec for further instructions or a replacement.
The recalled product
- Product
- Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Ostomy Supplies
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 7F00987
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · ConvaTec, Inc
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- HighConvaTec EsteemBody drainable pouch REF 423643 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423657 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423653 may leak
FDA (Devices) · 2026-03-25
Same hazard · mis labeling
See all →- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02