Every recall we track for Sonendo Inc — 3 in all — plus the complaints and injury reports the public filed about them.
Sonendo recalls GentleWave Posterior CleanFlow Procedure Instrument with Matrices (REF GW-PST-PI01) due to erroneous unit carton labels. No action needed as labels don't affect safety.
Sonendo recalls GentleWave APM Procedure Instrument with Matrix REF GW-APM-PI02 due to erroneous unit carton labels. Affected units have specific UDI-DI codes and lot numbers.
Sonendo recalls Gentlewave FG-002-0001 devices with specific lot numbers due to foot pedal malfunction causing extended operation after release. Affected users should contact Sonendo for details.
