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Sonendo Inc FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02Class IIOct 14, 2022Procedure Instruments with erroneous unit carton labels. |
| GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01Class IIOct 14, 2022Procedure Instruments with erroneous unit carton labels. |