Sonendo Inc recalls GENTLEWAVE REF: FG-002-0001

Recall date

October 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2162-2020

FDA classification

Class II

Brand / firm

Sonendo Inc

Sold / distributed

U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GENTLEWAVE REF: FG-002-0001