Class II — Neuronetrix Solutions, LLC dba Cognision
| Recalling firm | Neuronetrix Solutions, LLC |
|---|---|
| Registered facility | NEURONETRIX SOLUTIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia |
| 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. |
| Quantity | 3,108 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2019-11-07 |
| Classified | 2019-12-12 |
| Terminated | 2020-10-26 |
| Recall number | Z-0675-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Neuronetrix Solutions, LLC dba Cognision (Z-0675-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84324/
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