Class II — Potential Health Hazard

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

Servo Humidifier 163 Recalled by Teleflex Medical Due to Cracks may occur at the 15mm and 22mm...

Date: December 3, 2015
Company: Teleflex Medical
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 Teleflex Medical directly.

Affected Products

Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.

Quantity: 2,700 ea.

Why Was This Recalled?

Cracks may occur at the 15mm and 22mm ISO female connector.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teleflex Medical

Teleflex Medical has 204 total recalls tracked by RecallDetector.

Related Recalls

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