Z-0233-2023Class II

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

Name: Z-0233-2023 GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Creator: Sonendo Inc
Published: 2022-10-14
License: https://open.fda.gov/license/

Sonendo Inc / initiated 2022-10-14 / Open, Classified / root cause: labeling and UDI

FDA source

Sonendo Inc began a recall of GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 on 2022-10-14. FDA classified it as Class II and gives the reason as "Procedure Instruments with erroneous unit carton labels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0233-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-14
Posted: 2022-11-14
Recalling firm: Sonendo Inc
Product: GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Product code: ELC Scaler, Ultrasonic
Reason for recall: Procedure Instruments with erroneous unit carton labels.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 10/14/2022, the firm sent an "URGENT PRODUCT ADVISORY NOTICE" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes: a) The GentleWave brand identification; b) The Sonendo brand identification; c) Information such as: "Manufactured by:" and various ISO informational labeling symbols Customers are instructed: -Complete and return (fax or email) the Customer Acknowledgement Letter. -No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error. For questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to [email protected]
Quantity in commerce: 15 instruments
Distribution: Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Product codes and lots: GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0233-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0233-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-14
Z-0234-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-14

Product code ELC

K190359Class IISonendo GentleWave SystemSonendo, Inc. / cleared 2019-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)