Neuronetics NeuroStar Advanced Therapy Systems
The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Neuronetics, Inc. recalled the NeuroStar Advanced Therapy System because cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. The recall began August 24, 2026, and was added to the FDA's Enforcement Report on October 9, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects
- UDI-DI
- 00869378000100
- 3.0
- 00869378000117
- 2.X
- 3.2
- 00869378000193
- 00869378000155
- 3.6
- 120V
- 00850005944058
- 3.7
- 00850005944522
- 3.8
- 00850005944621
Details
- Company began the recall
- Event ID
- 99812
- Company
- Neuronetics, Inc.
- Hazard
- Device defect
- Quantity recalled
- 179 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
