Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following Recalled by ConvaTec, Inc Due to ConvaTec has received complaints associated with use of...

Date: September 6, 2019
Company: ConvaTec, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ConvaTec, Inc directly.

Affected Products

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management

Quantity: 8,008131 skin barriers

Why Was This Recalled?

ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.

Where Was This Sold?

Worldwide distributions.

About ConvaTec, Inc

ConvaTec, Inc has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report