Neuronetrix Solutions, LLC dba Cognision 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Neuronetrix Solutions, LLC dba Cognision
Lot Codes / Batch Numbers
Kit lot codes: NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 (containing Wave Prep lot codes: 30656).
Products Sold
Kit lot codes: NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 (containing Wave Prep lot codes: 30656).
Neuronetrix Solutions, LLC dba Cognision is recalling Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-elect due to Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Recommended Action
Per FDA guidance
Cognison notified customers and/or end users via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep cups were initially notified by phone on 11/7/2019. All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take: Please review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above. Customers have been instructed to dispose of the affected product as medical waste. Customer to return notice via email to support@cognision.com. If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product. Alternatively, you mail email support@cognision.com and provide this information
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026