Class II — Sonendo Inc
| Recalling firm | Sonendo, Inc. |
|---|---|
| Registered facility | SONENDO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The console would continue to run for extended period when the foot pedal was released. |
| Product | GENTLEWAVE REF: FG-002-0001 |
| Quantity | 460 foot pedals |
| Distribution | U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees. |
| Initiated | 2019-10-23 |
| Classified | 2020-05-28 |
| Terminated | 2022-01-20 |
| Recall number | Z-2162-2020 |
| 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-2162-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85593/
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