Laguna Hills, CA, United States
Sonendo Inc recalls
2 recalls recorded since 2018, most recently on 14 October 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 October 2022
- Reason
- Procedure Instruments with erroneous unit carton labels.
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0233-2023, Z-0234-2023
- GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
- GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Terminated Class II Medical devices
- Recall started
- 23 October 2019
- Terminated
- 20 January 2022
- Reason
- The console would continue to run for extended period when the foot pedal was released.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2162-2020
- GENTLEWAVE REF: FG-002-0001
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.