EEG Info Recalls EEG NeuroAmp Devices Due to Mislabeling
EEG Info is recalling EEG NeuroAmp devices because of a potential risk associated with mislabeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves mislabeling, which aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
EEG Info, Inc. is recalling the EEG NeuroAmp device, including models CS 10090 and CS 10137, used for biofeedback and relaxation. The recall involves 1,308 units with serial numbers ranging from 0001 to 3343.
The company identified a potential risk associated with the mislabeling of certain devices. The affected units were distributed nationwide.
Consumers should stop using the recalled devices and contact EEG Info for further instructions.
The recalled product
- Product
- EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
- Manufacturer
- EEG Info
- Hazard
- Affected units
- 1,308
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: 0001-3343.
Distribution
Distributed nationwide across the United States.
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