FDA Medical Device Recalls (openFDA)
Sonendo Inc: GENTLEWAVE REF: FG-002-0001
- Recall number
- Z-2162-2020
- Recalling firm
- Sonendo Inc
- Product
- GENTLEWAVE REF: FG-002-0001
- Status
- Terminated
- Initiated
- 2019-10-23
- Posted
- not on file
- Terminated
- 2022-01-20
- Reason
- The console would continue to run for extended period when the foot pedal was released.
- 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 complaints@sonendo.com.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 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