Product Wiki · Recalls · U.S. FDA — Device Enforcement

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro… — recall Z-0675-2020

U.S. FDA — Device Enforcement · United States · 2019-11-07 · Class II

As described by U.S. FDA — Device Enforcement: 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 cont

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0675-2020
Date of alert
2019-11-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Neuronetrix Solutions, LLC dba Cognision
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution.
Reported risk: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.