Sonendo Gentlewave FG-002-0001 Console May Run After Foot Pedal Release

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Recalling firmSonendo Inc26051 Merit Cir Ste 104, N/A · Laguna Hills, CA 92653-7008

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Sonendo is recalling Gentlewave FG-002-0001 devices with certain lot numbers because the foot pedal may cause the console to stay on after being released. This could lead to unintended operation and potential safety risks.

Why it’s dangerous

The console may continue running after the foot pedal is released, leading to unintended operation. This could cause the device to remain active when it should be off, potentially causing safety issues.

Who’s affected

Users of Gentlewave FG-002-0001 devices with specific lot numbers are affected. Those using the device for therapeutic purposes are most at risk due to potential unintended operation.

How to tell if you have this one

Check the lot numbers on your device: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330.

Brand
Sonendo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Identify your device's lot number from the list provided: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330.

✎ GovInfoNow

Questions people ask

What is the hazard with this device?

The console may continue running for extended periods after the foot pedal is released, leading to unintended operation.

How can I tell if my device is affected?

Check the lot number on your device against the list: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330.

What should I do if my device is affected?

Contact Sonendo for further instructions on how to address the issue.

Take action

Contact Sonendo

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

✉️ Open in email

Subject: Recall Z-2162-2020 — Sonendo Sonendo

Hello,

I own a Sonendo that is covered by recall Z-2162-2020 from Sonendo.

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-2162-2020 (October 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2162-2020 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.

Sonendo Inc recalls GENTLEWAVE REF: FG-002-0001

Use caution until it’s fixed