Documentary record · POST-MARKET SAFETY MONITORING UPDATE

TGA adds eight ARTG entries to its list of ventilator, CPAP and BiPAP devices unaffected by foam-material concerns

LIST UPDATED

Event date

September 1, 2026

Jurisdiction

Australia

Issuing body

TGA

Action type

POST-MARKET SAFETY MONITORING UPDATE

Lifecycle state

LIST UPDATED

Verification date

1 September 2026

None. A list of devices reported as unaffected. It is not a recall, and the listed products are not subject to any action.

What this establishes

  • Eight ARTG entries were added to the unaffected list on 1 September.

What this does not establish

  • That any device has been recalled.
  • That affected-device status has changed for any other product.

Why it matters

Recorded because the inverse error is common: an unaffected-devices list is routinely reported as if it were a recall list. Post-market surveillance records need their polarity stated.

Primary source

Register: data/events.json · record id tga-respiratory-devices-2026-09-01.