Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below…
Neuronetics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neuronetics, Inc. · 3222 Phoenixville Pike · Malvern, PA · 19355-9615
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
81-01315-000. | NeuroStar 2.0 US |
81-02315-000. | NeuroStar 3.0 US |
81-25000-100. | NeuroStar 2.X to 3.2 Upgrade Kit |
81-35000-000. | NeuroStar Upgrade Kit 3.0 US |
81-03315-000. | NeuroStar Mobile Console 3.6, 120V, US |
81-04315-000. | NeuroStar Mobile Console 3.7, 120V, US |
81-05315-000. | NeuroStar Mobile Console 3.8, 120V, US |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 81-01315-00000869378000100NeuroStar 2.0 US; ; UDI-DI: 00869378000100. 81-02315-00000869378000117NeuroStar 3.0 US; ; UDI-DI: 00869378000117. 81-25000-10000869378000193NeuroStar 2.X to 3.2 Upgrade Kit; ; UDI-DI: 00869378000193. 81-35000-00000869378000155NeuroStar Upgrade Kit 3.0 US; ; UDI-DI: 00869378000155. 81-03315-00000850005944058NeuroStar Mobile Console 3.6, 120V, US; ; UDI-DI: 00850005944058. 81-04315-00000850005944522NeuroStar Mobile Console 3.7, 120V, US; ; UDI-DI: 00850005944522. 81-01000-200.00850005944621NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000; UDI-DI: 00850005944621. NeuroStar HP Coil Assembly Coil Serial Numbers: 40203, 40208, 40202, 40204, 40206, 40205, 40207, 40209, 40210, 40211, 40212, 40213, 40214, 40215, 40216, 40217, 40218, 40219, 40220, 40221, 40222, 40223, 40224, 40225, 40227, 40228, 40226, 40229, 40230, 40231, 40232, 40233, 40234, 40236, 40235, 40238, 40239, 40240, 40241, 40242, 40243, 40244, 40245, 40246, 40247, 40248, 40249, 40250, 40251, 40252, 40253, 40254, 40255, 40256, 40257, 40258, 40259, 40260, 40261, 40262, 40263, 40265, 40266, 40267, 40264, 40283, 40284, 40285, 40286, 40287, 40288, 40289, 40290, 40291, 40293, 40292, 40294, 40295, 40296, 40297, 40298, 40299, 40300, 40301, 40302, 40303, 40304, 40305, 40306, 40307, 40308, 40309, 40310, 40311, 40312, 40313, 40314, 40315, 40316, 40317, 40318, 40320, 40319, 40321, 40322, 40323, 40324, 40325, 40326, 40327, 40328, 40329, 40331, 40332, 40333, 40334, 40335, 40336, 40337, 40338, 40339, 40340, 40341, 40342, 40343, 40344, 40347, 40346, 40345, 40348, 40349, 40350, 40353, 40352, 40351, 40354, 40355, 40356, 40357, 40358, 40359, 40360, 40371, 40372, 40373, 40374, 40375, 40376, 30643, 40274, 30638, 40281, 40199, 30671, 40201, 40272, 30641, 40278, 30646, 30653, 30640, 30647, 30652, 40275, 30648, 40197, 40279, 30650, 30639, 30623, 40198, 40280, 40270, 30645, 30654, 30636, 40200, 30635, 40282, 30606, 30607, 30608, 30609, 30610, 30611, 30624, 30625, 30630, 30631, 30632, 30633, 30634, 30655, 30656, 30657, 30658, 30659, 30660, 30622, 30621, 30626, 30614, 30620, 30616, 30619, 30615, 30617, 30661, 30662, 30663, 30664, 30665, 30627, 30628, 30629, 30644, 40268, 40269. - Amount recalled
- 179 units
Where it was sold
- Nationwide
Why it was recalled
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Neuronetics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.