Sonendo Inc GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Brand
Sonendo Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
Sonendo Inc is recalling GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 due to Procedure Instruments with erroneous unit carton labels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Procedure Instruments with erroneous unit carton labels.
Recommended Action
Per FDA guidance
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 complaints@sonendo.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026