---
title: "Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a t... — FDA record Z-0903-2025 | Is It on Recall"
description: "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 b"
url: https://isitonrecall.com/recall/fda-device-z-0903-2025-esteem-synergy-stomahesive-skin-barrier-part-of-esteem-synergy-which-is-a-two-piece-ostomy-system-co/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an ... — FDA record Z-0903-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: ConvaTec, Inc
- **Quantity**: 240
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0903-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0903-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution to states of: OH, NY, IL

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Illinois](https://isitonrecall.com/state/illinois/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Jan 22, 2025
- **Recall initiation date**: Nov 29, 2024
- **Center classification date**: Jan 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0903-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ConvaTec, Inc records](https://isitonrecall.com/brand/convatec-inc/)