Class II — Potential Health Hazard

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

Oxygen Masks Recalled by ConvaTec, Inc Due to Reports of tubing detaching from oxygen masks either...

Date: May 10, 2017
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

Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

Quantity: 816,709

Why Was This Recalled?

Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

Where Was This Sold?

This product was distributed to 13 states: CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA

Affected (13 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