Baby Deaths Associated With Home-use Foetal Heart Monitors
Recall Summary Home-use fetal heart monitors sold across Australia are being recalled because they can give false readings that create a false sense of security, leading parents to delay seeking medical care when their baby actually needs it. Reports have linked these devices to infant deaths caused by delayed medical attention. This recall affects all home-use fetal heart monitors distributed in Australia.
- Reason
- Baby deaths have been associated with home use of foetal heart monitors, which can give false reassurance and should not replace assessment by a qualified healthcare professional.
- Classification
- Class II
- Category
- medical device recall
- Country
- Australia
- Agency
- Therapeutic Goods Administration
- Recall date
- 2025-08-14
- Status
- Ongoing
- Distribution
- Australia-wide
Official recall notice from Therapeutic Goods Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/b5acf76a-b427-40f6-a37a-edb5dee9c748