Neuronetrix Solutions, LLC dba Cognision: Medical Device Recall in 2019 - (Recall #: Z-0675-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 7, 2019

Date Posted: December 18, 2019

Recall Number: Z-0675-2020

Event ID: 84324

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,108 units

Code Information:

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).

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated