Sonendo Inc recalls GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Recall date

October 14, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0234-2023

FDA classification

Class II

Brand / firm

Sonendo Inc

Sold / distributed

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

Why it was recalled

Procedure Instruments with erroneous unit carton labels.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01