Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology Recalled by Neuralynx Inc Due to Atlas Stim Headbox (ASHB) was delivered to US...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Neuralynx Inc directly.
Affected Products
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Quantity: 15
Why Was This Recalled?
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Neuralynx Inc
Neuralynx Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report