PCA 4000 Dental Curing Units May Not Fully Cure Resins
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. No illnesses or injuries have been reported, but improper curing of dental materials poses a risk of harm to patients through compromised restorations, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Envisiontec US Llc is recalling PCA 4000 Curing Units (SKU number ACC-06-1000) distributed nationwide in the United States. A total of 172 units are affected by this recall.
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. Improper curing can result in dental restorations that do not meet quality and durability standards.
This recall affects dental practices and practitioners using PCA 4000 units for curing dental resins. The recall does not apply to units sold to industrial customers for curing industrial resins. Users of affected units should discontinue use and contact Envisiontec US Llc for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Envisiontec US Llc
- Hazard
- incomplete-curing
- product-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units SKU number ACC-06-1000
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27