WAVi Co.: Medical Device Recall in 2024 - (Recall #: Z-1942-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: December 8, 2023

Date Posted: June 12, 2024

Recall Number: Z-1942-2024

Event ID: 94498

Reason for Recall:

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

Status: Ongoing

Product Quantity: 281

Code Information:

Desktop software version 1.0.0.2

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated