Z-0903-2025Class II

Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system...

Name: Z-0903-2025 Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system...
Creator: ConvaTec, Inc
Published: 2024-11-29
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2024-11-29 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of 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... on 2024-11-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0903-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-29
Posted: 2025-01-10
Recalling firm: ConvaTec Limited
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
Product code: EXE Protector, Ostomy
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/29/2024, "URGENT: MEDICAL DEVICE RECALL" notices were emailed to customers who were asked to do the following: 1) Review this notification and ensure all relevant stakeholders are aware of this recall communication and any action required. 2) If you have distributed affected product beyond your establishment, identify your customers, and notify them at once of this product recall. Your notification to your customers can be enhanced by including a copy of this recall notification letter. 3) Immediately examine your inventory and quarantine affected product Upon receipt and review of satisfactory information, formal authorization from a firm Representative will be provided to proceed with product destruction. 4) Firm will provide a Certificate of Destruction (COD) to complete. 5) Immediately destroy all affected product and provide firm with a signed Certificate of Destruction (COD) as evidence to support reconciliation and regulatory reporting. 6) Complete and return the response form via email to [email protected] 9. Your account will be credited for destroyed product upon receipt of the response form and Certificate of Destruction (COD). If you need any further information or support concerning this recall, please contact any of the following [email protected], [email protected] or telephone 800-582-6514.
Quantity in commerce: 240
Distribution: US distribution to states of: OH, NY, IL
Product codes and lots: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0903-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0903-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code EXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)