Envisiontec US Llc recalls
Every recall we track for Envisiontec US Llc — 3 in all, all from 2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Envisiontec US Llc peaked in 2022 (3); 3 since 2017.
All FDA recall records for Envisiontec US Llc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 3 | 0 | 3 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Envisiontec US Llc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Envisiontec US Llc recalls
2 shown- Lower riskMedical device
Envisiontec US Llc recalls PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall
Envisiontec recalls PCA 4000 curing units (SKU ACC-06-1000) that may not fully cure dental resins to specifications. Affected units sold to dental professionals.
EnvisiontecJan 20, 2022 - Lower riskMedical device
Envisiontec US Llc recalls FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Envisiontec recalls FLEXCERA SMILE dental resins made between April 2021 and September 2021 due to being produced in a non-FDA-registered facility and mislabeled as German. Affected products have specific lot numbers.
EnvisiontecJan 6, 2022
Envisiontec US Llc recall questions
How many recalls has Envisiontec US Llc had?
3 recalls from Envisiontec US Llc are on record with U.S. safety agencies, from 2022.
What is the most recent Envisiontec US Llc recall?
Envisiontec US Llc recalls PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall, dated Jan 20, 2022. Every Envisiontec US Llc recall is listed on this page, newest first.
What should I do if I have a recalled Envisiontec US Llc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Envisiontec US Llc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.