Envisiontec US recalls

Envisiontec US has 3 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 16 Mar 2022. 3 are still ongoing. The most frequent reason is labeling errors.

Total recalls3since 2022

Last 12 months0reported

Class I00% of total

Ongoing3latest 16 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 0 0%Class II 3 100%Class III 0 0%

Why envisiontec us is recalled

Labeling Errors267%
Device Malfunction133%

Product types

Dental Devices267%
Other Medical Devices133%

By year

20223100%

Ongoing envisiontec us recalls

3 active

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS II	PCA 4000 Curing Units recalled by Envisiontec US	Envisiontec US	Device Malfunction	Nationwide
23 Feb 2022Device	CLASS II	Flexcera Base -a Dental resins recalled by Envisiontec US	Envisiontec US	Labeling Errors	Nationwide
23 Feb 2022Device	CLASS II	Flexcera Smile -a Dental resins recalled by Envisiontec US	Envisiontec US	Labeling Errors	Nationwide

All envisiontec us recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS II	PCA 4000 Curing Units recalled by Envisiontec US	Envisiontec US	Device Malfunction	Nationwide
23 Feb 2022Device	CLASS II	Flexcera Base -a Dental resins recalled by Envisiontec US	Envisiontec US	Labeling Errors	Nationwide
23 Feb 2022Device	CLASS II	Flexcera Smile -a Dental resins recalled by Envisiontec US	Envisiontec US	Labeling Errors	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.