Sonendo, Inc.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- SONENDO, INC. FEI 3010817521 · CA
Recalls & enforcement
- Class IIOngoing2022-10-14Procedure Instruments with erroneous unit carton labels.
- Class IITerminated2019-10-23The console would continue to run for extended period when the foot pedal was released.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Sonendo, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046931-sonendo-inc/
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