Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PCA 4000 Curing Units Recalled by Envisiontec US Llc Due to The PCA 4000 may not fully cure EnvisionTEC...

Date: January 20, 2022
Company: Envisiontec US Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Envisiontec US Llc directly.

Affected Products

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.

Quantity: 172 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Envisiontec US Llc

Envisiontec US Llc has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report