WAV: Research EEG Desktop System Recall - FDA Warning Letter

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Contact the company & request your remedy

Recalling firmWAVi Co.3857 N Steele St Ste 1293, N/A · Denver, CO 80205-4996

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

WAVi is recalling their research EEG desktop system components because they received an FDA warning letter about closing their research study. This recall affects users of the WAVi Research EEG Desktop Software version 1.0.0.2 with HRV ear clips.

Why it’s dangerous

The system was recalled because WAVi received an FDA warning letter that led them to close their research study. The hazard is not described in terms of physical risk to users but rather a research-related issue.

Who’s affected

Researchers and users of WAVi's EEG research system who have the software version 1.0.0.2 with HRV ear clips are affected. The risk is highest for those using the system in ongoing research studies.

How to tell if you have this one

Check if you have WAVi Research EEG Desktop Software version 1.0.0.2 with the included HRV ear clips. The system also includes WAVi SCAN EEG System accessories and headsets.

Brand
WAVi
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify if you have WAVi Research EEG Desktop Software version 1.0.0.2 with HRV ear clips.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

WAVi received an FDA warning letter that required them to close their research study, so they are recalling the system components.

Is there a remedy for this recall?

The recall record does not specify any remedy.

What specific product is affected?

The affected product is WAVi Research EEG Desktop Software version 1.0.0.2 with HRV ear clips.

Take action

Contact WAVi

We’ve drafted a message you can send WAVi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1942-2024 — WAVi WAVi

Hello,

I own a WAVi that is covered by recall Z-1942-2024 from WAVi.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1942-2024 (December 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1942-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

WAVi Co. recalls WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and

Recall notice