Sonendo Recalls
3 recalls on record · June 3, 2020 to November 23, 2022 · Medical Devices
Recalls by year
20
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 23, 2022Medical DevicesFDA
Sonendo Inc recalls GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Hazard: Procedure Instruments with erroneous unit carton labels.
November 23, 2022Medical DevicesFDA
Sonendo Inc recalls GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Hazard: Procedure Instruments with erroneous unit carton labels.
June 3, 2020Medical DevicesFDA
Sonendo Inc recalls GENTLEWAVE REF: FG-002-0001
Hazard: The console would continue to run for extended period when the foot pedal was released.