Envisiontec recalls

2 official recalls and safety alerts involving Envisiontec since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Envisiontec or the relevant agency.

1. 2022-03-16
2. US
   Drugs & medicalClass II

   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 will not impact…

   The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

   FDA · DeviceEnvisiontec US LlcUS NationwideOfficial notice →
3. 2022-02-23
4. US
   Drugs & medicalClass II

   Envisiontec US Llc recalls FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

   Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

   FDA · DeviceEnvisiontec US LlcUS Nationwide distribution.Official notice →