Class II — Sonendo Inc
| Recalling firm | Sonendo, Inc. |
|---|---|
| Registered facility | SONENDO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Procedure Instruments with erroneous unit carton labels. |
| Product | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 |
| Quantity | 16 instruments |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada. |
| Initiated | 2022-10-14 |
| Classified | 2022-11-14 |
| Recall number | Z-0234-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sonendo Inc (Z-0234-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91045/
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