ConvaTec, Inc: Medical Device Recall in 2018 - (Recall #: Z-1890-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 25, 2018

Date Posted: May 23, 2018

Recall Number: Z-1890-2018

Event ID: 79953

Reason for Recall:

It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

Status: Terminated

Product Quantity: 200 boxes of 10

Code Information:

Lot Number 7F00987

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated