Reported Nov 23, 2022 · Ongoing
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Sonendo Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sonendo Inc · 26051 Merit Cir Ste 104 · Laguna Hills, CA · 92653-7008
Is this the product you have?
- GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
- Lot codes and dates
- GentleWave System Anterior/Premolar Procedure
- Instrument (GW-APM-PI02) UDI-DI Code00858395006318
- Lot NumberW2022080941R
- Amount recalled
- 15 instruments
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- OH
Why it was recalled
Procedure Instruments with erroneous unit carton labels.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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