Cognision — Class II medical device recall Z-0675-2020
Terminated recall by Neuronetrix Solutions, LLC dba Cognision, reported 2019-12-18, distributed nationwide. Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
| Recall number | Z-0675-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuronetrix Solutions, LLC dba Cognision, Louisville, KY, United States |
| Recall initiated | 2019-11-07 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,108 units |
| Pathogens | burkholderia |
| Lot numbers | 30656, NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 |
| Model numbers | 3000, PN-1720 |
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.
Reason for recall
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0675-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.