# FDA recall Z-2162-2020

> **Sonendo Inc** · Class II · device recall initiated 2019-10-23.

## Product

GENTLEWAVE REF: FG-002-0001

## Reason for recall

The console would continue to run for extended period when the foot pedal was released.

## 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.

## Key facts

- **Recall number:** Z-2162-2020
- **Recalling firm:** Sonendo Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-23
- **Report date:** 2020-06-03
- **Termination date:** 2022-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Laguna Hills, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2020

## Citation

> AI Analytics. FDA recall Z-2162-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2162-2020. Source: US FDA. Licensed CC0.

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