Neuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
Neuronetics is recalling 179 NeuroStar Advanced Therapy Systems because the cables in the HP Coil Assembly do not meet product specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the cables in the HP Coil Assembly do not meet product specifications. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Neuronetics, Inc. is recalling 179 units of the NeuroStar Advanced Therapy System. The affected systems include the NeuroStar 2.0 US, NeuroStar 3.0 US, NeuroStar 2.X to 3.2 Upgrade Kit, NeuroStar Upgrade Kit 3.0 US, and NeuroStar Mobile Console models 3.6, 3.7, and 3.8. The recall involves the NeuroStar HP Coil Assembly, Part Number 81-01000-200.
The recall was initiated because the cables in the HP Coil Assembly are not in conformance with the product specifications required for production. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The affected products were distributed worldwide, including the United States, Japan, and South Korea. Consumers and healthcare providers should stop using the affected units and contact Neuronetics for instructions on how to proceed.
The recalled product
- Product
- 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. NeuroStar 3.0 US; Part Number: 81-02315-000. 3. NeuroStar 2.X…
- Manufacturer
- Neuronetics, Inc.
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 179
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- NeuroStar Software Versions 3.6
- 3.7
- 3.8 1. NeuroStar 2.0 US
- Part Number: 81-01315-000
- UDI-DI: 00869378000100. 2. NeuroStar 3.0 US
- Part Number: 81-02315-000
- UDI-DI: 00869378000117. 3. NeuroStar 2.X to 3.2 Upgrade Kit
- Part Number: 81-25000-100
- UDI-DI: 00869378000193. 4. NeuroStar Upgrade Kit 3.0 US
- Part Number: 81-35000-000
- UDI-DI: 00869378000155. 5. NeuroStar Mobile Console 3.6
- 120V
- US
- Part Number: 81-03315-000
- UDI-DI: 00850005944058. 6. NeuroStar Mobile Console 3.7
- Part Number: 81-04315-000
- UDI-DI: 00850005944522. 7. NeuroStar Mobile Console 3.8
- Part Number: 81-05315-000
- 40208
- 40202
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · manufacturing defect
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
Similar recalls
- SevereAlpha Omega Engineering Recalls Neuro Omega Systems Due to Tissue Harm Risk
FDA (Devices) · 2019-05-15
- HighCyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
FDA (Devices) · 2017-08-23
- ModerateArrow International Recalls Nerve Block Catheter Kits Due to Labeling Error
FDA (Devices) · 2013-12-25
- ModerateArjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims
FDA (Devices) · 2015-03-11
- SevereCodman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
FDA (Devices) · 2013-02-27
- HighCodman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns
FDA (Devices) · 2013-02-27