Class II — Potential Health Hazard

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

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended Recalled by ConvaTec, Inc Due to The Nebulizer mask malfunctions in that there is...

Date: November 11, 2015
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

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

Quantity: 3,605,700 pieces

Why Was This Recalled?

The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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