# FDA recall Z-0233-2023

> **Sonendo Inc** · Class II · device recall initiated 2022-10-14.

## Product

GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

## Reason for recall

Procedure Instruments with erroneous unit carton labels.

## Distribution

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

## Key facts

- **Recall number:** Z-0233-2023
- **Recalling firm:** Sonendo Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-14
- **Report date:** 2022-11-23

- **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-0233-2023

## Citation

> AI Analytics. FDA recall Z-0233-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0233-2023. Source: US FDA. Licensed CC0.

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