ConvaTec, Inc: Medical Device Recall in 2022 - (Recall #: Z-0127-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.

Product Classification:

Class II

Date Initiated: August 16, 2022

Date Posted: November 2, 2022

Recall Number: Z-0127-2023

Event ID: 90856

Reason for Recall:

impaired functionality of the release liner

Status: Ongoing

Product Quantity: 5284 units

Code Information:

UDI/DI: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated