Envisiontec US Llc: Medical Device Recall in 2022 - (Recall #: Z-0746-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
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 units sold to industrial customers.
Product Classification:
Class II
Date Initiated: January 20, 2022
Date Posted: March 16, 2022
Recall Number: Z-0746-2022
Event ID: 89534
Reason for Recall:
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Status: Ongoing
Product Quantity: 172 units
Code Information:
All units SKU number ACC-06-1000
Distribution Pattern:
US Nationwide
Voluntary or Mandated:
Voluntary: Firm initiated