Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Tracoe Mini 3.0mm Tube Recalled by Bryan Medical Inc Due to Mislabeling

Date: April 17, 2013
Company: Bryan Medical 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 Bryan Medical Inc directly.

Affected Products

Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

Quantity: 5 units

Why Was This Recalled?

The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Where Was This Sold?

This product was distributed to 2 states: AL, KY

Affected (2 states)Not affected

About Bryan Medical Inc

Bryan Medical Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

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