Oventus Manufacturing Pty Ltd — O2Vent T Adjuster Assembly

PRA number


Published date

Product description

The O2Vent T is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnoea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. The O2Vent T is for prescription use only.

Please note there is a separate recall for the O2Vent T Instructions for use (see PRA2017/15831).
Identifying features

Other identifying numbers

See attached list.

Reasons the product is recalled

The manufacturer has determined that a correction to the Adjuster Assembly part of the O2Vent T device is necessary and must be returned for rework. The Adjuster Assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment.

The hazards to consumers

The performance of the device and risk to patient safety is affected by the faulty adhesion of the Adjuster Assembly part.

What consumers should do

Consumers should stop using the product and return it to Oventus Manufacturing for a rework. Consumers can call Oventus on 1300 533 159 for further information.


Oventus Pty Ltd

Where the product was sold


Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category