Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GENTLEWAVE REF: FG-002-0001 Recalled by Sonendo Inc Due to The console would continue to run for extended...

Date: October 23, 2019
Company: Sonendo Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sonendo Inc directly.

Affected Products

GENTLEWAVE REF: FG-002-0001

Quantity: 460 foot pedals

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 46 states: AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC

Affected (46 states)Not affected

About Sonendo Inc

Sonendo Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report