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