| TGA Action ID |
RC-2025-RN-00164-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
High Filtration Surgical Face Masks with Ties Level 3
Batch Numbers: 51045,50825,50836,43313
Expiry Dates: June 2029, April 2029, March 2029, January 2026 |
| ARTG Number |
109872 |
| Action Type |
Recall |
| Action Level |
Wholesale |
| Hazard Classification |
Class II |
| Reason for the Action |
The Therapeutic Goods Administration (TGA) conducted a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).
Med-Con Pty Ltd was found to have supplied four batches of their Mask, surgical, single use, which failed the TGA's fluid resistance tests at level 3. The fluid resistance test measures the mask's ability to protect against the penetration of blood and/or body fluids, as outlined in the Australian Standard: AS 4381:2015.
Updated 29/07/2026: The affected batches will be recalled. |
| Instructions for Customers/Users |
Customers are advised to quarantine the affected batches. TGA and Sponsor are still investigating, and further information will be provided once the investigation is complete.
Updated 29/07/2026: Customers are to return the affected batches as outlined in the customer letter. |
| Action Commencement Date |
29/07/2026 |
| Responsible Entity |
|
| Contact Information |
03 5822 6600 - Peita Sleeth, Med-Con |