| TGA Action ID |
RC-2025-RN-01052-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Drive Devilbiss Home CPAP Unit
Product Identifiers: DV56SE, DV55SE, DV54AU-HH, DV54UK-P, DV54SE-P, DV54SE-HH, DV51SE, DV51D, DV51AU-HH, DV51AU, DV51SE-HH |
| ARTG Number |
277439 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has conducted a post-market review of ventilators and CPAP and BiPAP devices, in particular to identify and address risks posed by polyester-based polyurethane foam (PE-PUR) used as a soundproofing material in CPAP devices.
The TGA has identified that PE-PUR foam may cause safety and health risks when used in the breathing gas pathway of ventilators and CPAP and BiPAP devices. This is due to the risk of PE-PUR foam degrading into small particulates and releasing volatile organic compounds (VOCs) that may be inhaled or ingested by a user or patient.
We have not received any reports that use of the Devices have resulted in serious injury or death at this time, however the devices are being recalled as a precautionary measure against potential risks that may become apparent in the future, in light of emerging evidence of the dangers of PE-PUR foam.
This recall was required by the Therapeutic Goods Administration in accordance with Section 41KA of the Therapeutic Goods Act 1989, as there is incomplete data available to demonstrate the long-term safety of the Device over its intended service life of 5 years. |
| Instructions for Customers/Users |
Customers should inspect their stock immediately and quarantine affected stock on hand to prevent further use.
Customers should return affected stock on hand with the completed customer response form to the address in the customer letter.
Drive Devilbiss will provide a refund for affected devices and can be contacted to arrange a refund.
This action has been finalised on 15/4/2026. |
| Action Commencement Date |
19/12/2025 |
| Responsible Entity |
|
| Contact Information |
0413 331 902 or cpapaus@drivemedical.com |