EEG NeuroAmp — Class II medical device recall Z-0526-2013
Terminated recall by EEG Info, reported 2012-12-26, distributed nationwide. EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated w
| Recall number | Z-0526-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EEG Info, Woodland Hills, CA, United States |
| Recall initiated | 2012-11-15 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,308 units |
| Reason classes | labeling |
| Serial numbers | 0001-3343 |
| Model numbers | 10090 |
Product
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Reason for recall
EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
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-0526-2013. 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.