Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cognision Recalled by Neuronetrix Solutions, LLC dba Cognision Due to Product has the potential to be contaminated with...

Date: November 7, 2019
Company: Neuronetrix Solutions, LLC dba Cognision
Status: Terminated
Source: FDA (Device)

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 Neuronetrix Solutions, LLC dba Cognision directly.

Affected Products

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.

Quantity: 3,108 units

Why Was This Recalled?

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Neuronetrix Solutions, LLC dba Cognision

Neuronetrix Solutions, LLC dba Cognision has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report