Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

WAVi Research EEG Desktop System is comprised of the WAVi Recalled by WAVi Co. Due to Following an FDA-issued Warning Letter, the firm requested...

Date: December 8, 2023
Company: WAVi Co.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact WAVi Co. directly.

Affected Products

WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

Quantity: 281

Why Was This Recalled?

Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

Where Was This Sold?

This product was distributed to 31 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NM, NY, NC, OH, OR, PA, TX, UT, VA, WA

Affected (31 states)Not affected

About WAVi Co.

WAVi Co. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report