Sunstar Americas recalls

Sunstar Americas has 6 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 9 Mar 2022. 1 is still ongoing. The most frequent reason is sterility.

Total recalls6since 2020

Last 12 months0reported

Class I117% of total

Ongoing1latest 9 Mar 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 1 17%Class II 5 83%Class III 0 0%

Why sunstar americas is recalled

Sterility583%
Other Reasons117%

Product types

Other Medical Devices467%

By year

2022117%
2021467%
2020117%

Ongoing sunstar americas recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 Jan 2021Drug	CLASS II	Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 12%, Alcohol Free recalled	Sunstar Americas	Sterility	Nationwide

All sunstar americas recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022Device	CLASS II	Butler Clear Dip/case recalled by Sunstar Americas	Sunstar Americas	Other	Nationwide
16 Jun 2021Device	CLASS II	Sunstar G.U.M Perioshield Oral Health Rinse recalled by Sunstar Americas	Sunstar Americas	Sterility	Nationwide
21 Apr 2021Device	CLASS II	Sunstar Butler Clear Dip recalled by Sunstar Americas	Sunstar Americas	Sterility	IL
17 Mar 2021Device	CLASS II	Sunstar G.u.m recalled by Sunstar Americas	Sunstar Americas	Sterility	Nationwide
20 Jan 2021Drug	CLASS II	Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 12%, Alcohol Free recalled	Sunstar Americas	Sterility	Nationwide
2 Dec 2020Drug	CLASS I	Paroex (chlorhexidine gluconate) Oral Rinse, USP 12%, Alcohol Free recalled	Sunstar Americas	Sterility	Nationwide

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.