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Sonendo Inc recalls GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Recalled November 23, 2022 · FDA recall Z-0233-2023 · Sonendo
Hazard
Procedure Instruments with erroneous unit carton labels. · FDA Class II
Units
15 instruments
Sold at
Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Description
Procedure Instruments with erroneous unit carton labels.
Product
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Manufacturer(s)
Sonendo Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →