FDA Device recall Z-0234-2023
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 by Sonendo, citing procedure Instruments with erroneous unit carton labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0234-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-14 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sonendo |
| Distribution | US |
Product
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Reason
Procedure Instruments with erroneous unit carton labels.
Identifiers
| code_info | GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0234-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.