# FDA recall Z-0903-2025

> **ConvaTec, Inc** · Class II · device recall initiated 2024-11-29.

## 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 for recall

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

## Distribution

US distribution to states of: OH, NY, IL

## Key facts

- **Recall number:** Z-0903-2025
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-29
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0903-2025

## Citation

> AI Analytics. FDA recall Z-0903-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0903-2025. Source: US FDA. Licensed CC0.

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