Sonendo Inc: Medical Device Recall in 2022 - (Recall #: Z-0233-2023)

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 APM Procedure Instrument with Matrix REF GW-APM-PI02

Product Classification:

Class II

Date Initiated: October 14, 2022

Date Posted: November 23, 2022

Recall Number: Z-0233-2023

Event ID: 91045

Reason for Recall:

Procedure Instruments with erroneous unit carton labels.

Status: Ongoing

Product Quantity: 15 instruments

Code Information:

GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated