Sonendo recalls

Sonendo has 3 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 23 Nov 2022. 2 are still ongoing.

Total recalls3since 2020

Last 12 months0reported

Class I00% of total

Ongoing2latest 23 Nov 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why sonendo is recalled

Other Reasons3100%

Product types

Other Medical Devices3100%

By year

2022267%
2020133%

Ongoing sonendo recalls

2 active

Reported	Class	Recall	Company	Reason	Where
23 Nov 2022Device	CLASS II	GentleWave System Posterior CleanFlow Procedure Instrument recalled	Sonendo	Other	Nationwide
23 Nov 2022Device	CLASS II	GentleWave System APM Procedure Instrument with Matrix recalled	Sonendo	Other	Nationwide

All sonendo recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
23 Nov 2022Device	CLASS II	GentleWave System Posterior CleanFlow Procedure Instrument recalled	Sonendo	Other	Nationwide
23 Nov 2022Device	CLASS II	GentleWave System APM Procedure Instrument with Matrix recalled	Sonendo	Other	Nationwide
3 Jun 2020Device	CLASS II	Gentlewave REF: FG recalled by Sonendo	Sonendo	Other	46 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.