Z-2162-2020Class II

Gentlewave Ref: Fg-002-0001

Name: Z-2162-2020 Gentlewave Ref: Fg-002-0001
Creator: Sonendo Inc
Published: 2019-10-23
License: https://open.fda.gov/license/

Sonendo Inc / initiated 2019-10-23 / Terminated / root cause: design

FDA source

Sonendo Inc began a recall of GENTLEWAVE REF: FG-002-0001 on 2019-10-23. FDA classified it as Class II and gives the reason as "The console would continue to run for extended period when the foot pedal was released". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2162-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-23
Posted: 2020-05-28
Terminated: 2022-01-20
Recalling firm: Sonendo Inc
Product: Gentlewave Ref: Fg-002-0001
Product code: ELC Scaler, Ultrasonic
Reason for recall: The console would continue to run for extended period when the foot pedal was released.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/23/2019, "Urgent: Medical Device Recall" of a foot pedal, the firm provided information on how to recognize the device malfunction as: If the treatment fluid is continuously cycling after the foot pedal is released, this is a sign that the foot pedal is not working properly. The firm instructed customers to replace the current foot pedal with the new foot pedal that was sent with this notification. and instructed to: Attach the new foot pedal to the Foot Pedal connection located at the lower rear of the Console as instructed per IFU. The firm instructed customers to return the current foot pedal in the provided pre-paid FedEx box and send the enclosed acknowledgement letter to the firm by mail. The contact information was provided to customers as: Calls Monday through Friday 5:00 AM to 5:00 PM (Pacific Time) 1-844-468-5928 or email [email protected].
Quantity in commerce: 460 foot pedals
Distribution: U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.
Product codes and lots: Foot Pedal, P/N: 102-0186-001 of GENTLEWAVE REF: FG-002-0001 device: Lot#: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28

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)