Class II — Potential Health Hazard

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

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System Recalled by ConvaTec, Inc Due to The kit contains a flange that has a...

Date: January 17, 2024
Company: ConvaTec, Inc
Status: Ongoing
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

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

Quantity: 1,715 units

Why Was This Recalled?

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Where Was This Sold?

This product was distributed to 12 states: AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, TX

Affected (12 states)Not affected

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