Sonendo Inc: Medical Device Recall in 2022 - (Recall #: Z-0234-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Product Classification:

Class II

Date Initiated: October 14, 2022

Date Posted: November 23, 2022

Recall Number: Z-0234-2023

Event ID: 91045

Reason for Recall:

Procedure Instruments with erroneous unit carton labels.

Status: Ongoing

Product Quantity: 16 instruments

Code Information:

GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated