Sonendo Inc: Medical Device Recall in 2020 - (Recall #: Z-2162-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

GENTLEWAVE REF: FG-002-0001

Product Classification:

Class II

Date Initiated: October 23, 2019

Date Posted: June 3, 2020

Recall Number: Z-2162-2020

Event ID: 85593

Reason for Recall:

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

Status: Terminated

Product Quantity: 460 foot pedals

Code Information:

Foot Pedal, P/N: 102-0186-001 of GENTLEWAVE REF: FG-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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated