Reported Jun 3, 2020 · Terminated

GENTLEWAVE REF: FG-002-0001

Sonendo Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sonendo Inc · 26051 Merit Cir Ste 104 · Laguna Hills, CA · 92653-7008

Is this the product you have?

  • GENTLEWAVE REFFG-002-0001
Lot codes and dates
  • Foot Pedal
  • P/N102-0186-001
  • of GENTLEWAVE REFFG-002-0001
  • device
    • Lot#: 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
Amount recalled
460 foot pedals

Where it was sold

Why it was recalled

The console would continue to run for extended period when the foot pedal was released.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Sonendo Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 20, 2022 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.