FDAOctober 14, 2022device
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Procedure Instruments with erroneous unit carton labels.
What to do
FDA enforcement status: Ongoing
Brands named
sonendo
UPCs
00858395006318
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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