Malvern, PA, United States
Neuronetics, Inc. recalls
1 recall recorded since 2018, most recently on 24 August 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 August 2026
- Reason
- Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan and South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0142-2027
- NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroSt
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.