FDA Medical Device Recalls (openFDA)
Sonendo Inc: GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Recall number
- Z-0234-2023
- Recalling firm
- Sonendo Inc
- Product
- GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Status
- Open, Classified
- Initiated
- 2022-10-14
- Posted
- 2022-11-14
- Terminated
- not on file
- Reason
- Procedure Instruments with erroneous unit carton labels.
- 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 complaints@sonendo.com
- Quantity
- 16 instruments
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
- Lot, serial or model codes
- GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
- 510(k) numbers
- ["K190359"]
- PMA numbers
- not on file
- Product code
- ELC
- Firm FEI
- 3010817521
- Firm city
- Laguna Hills
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28