ConvaTec, Inc: Medical Device Recall in 2025 - (Recall #: Z-0903-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 29, 2024

Date Posted: January 22, 2025

Recall Number: Z-0903-2025

Event ID: 95955

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

Status: Ongoing

Product Quantity: 240

Code Information:

REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814

Distribution Pattern:

US distribution to states of: OH, NY, IL

Voluntary or Mandated:

Voluntary: Firm initiated