GentleWave System Posterior CleanFlow Procedure Instrument with… — Class II medical device recall Z-0234-2023
Ongoing recall by Sonendo Inc, reported 2022-11-23, distributed nationwide. Procedure Instruments with erroneous unit carton labels.
| Recall number | Z-0234-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sonendo Inc, Laguna Hills, CA, United States |
| Recall initiated | 2022-10-14 |
| Classified | 2022-11-14 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 16 instruments |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00195893912278 |
| Lot numbers | W2022080204R |
| Model numbers | GW-PST-PI01 |
Product
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Reason for recall
Procedure Instruments with erroneous unit carton labels.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0234-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.