WAVi Research EEG Desktop System is comprised of the WAVi Research… — Class II medical device recall Z-1942-2024
Ongoing recall by WAVi Co., reported 2024-06-12, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due
| Recall number | Z-1942-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | WAVi Co., Denver, CO, United States |
| Recall initiated | 2023-12-08 |
| Classified | 2024-05-31 |
| Reported by FDA | 2024-06-12 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NM, NV, NY, OH, OR, PA, TX, UT, VA, WA |
| Quantity | 281 |
Product
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).
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.
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-1942-2024. 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.