GENTLEWAVE REF: FG-002-0001 — Class II medical device recall Z-2162-2020
Terminated recall by Sonendo Inc, reported 2020-06-03, distributed in AK, AL, AZ, CA, CO, CT, DC, FL…. The console would continue to run for extended period when the foot pedal was released.
| Recall number | Z-2162-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sonendo Inc, Laguna Hills, CA, United States |
| Recall initiated | 2019-10-23 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-01-20 |
| Distributed | AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Quantity | 460 foot |
| Lot numbers | 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 |
| Model numbers | FG-002-0001 |
Product
GENTLEWAVE REF: FG-002-0001
Reason for recall
The console would continue to run for extended period when the foot pedal was released.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2162-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.