GentleWave System Posterior CleanFlow Procedure Instrument… recallZ-0234-2023 · Sonendo Inc · initiated Oct 14, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sonendo Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Procedure Instruments with erroneous unit carton labels.
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-0234-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 14, 2022
- Posted by the FDA
- Nov 14, 2022
- Recalling firm
- Sonendo Inc
- Quantity
- 16 instruments
- Product code
- ELC
- FDA submissions
- K190359
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Product description
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Code information (models, lots, serial numbers)
GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Posterior CleanFlow Procedure Instrument with Matrices FG-013-00004Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91045).
- Z-0233-2023 · Open, ClassifiedGentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page