Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
Ivoclar Vivadent is recalling Virtual XD Test Pack dental impression material because it may fail to set properly as it ages.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or severe injuries are reported, and the hazard is a functional defect (failure to set) rather than a toxicological or structural safety risk.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling Virtual XD Test Pack Heavy/Light Fast Set dental impression material, Product Code 646469. The recall involves 2,090 units in the United States, 331 units in Canada, and 465 units in Australia. The affected lots are TL4095 and TL4094, both with an expiration date of January 15, 2017.
The firm initiated the recall after receiving complaints that the dental material failed to set up. The source text notes that as the dental material ages, the set time may increase. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Dental professionals and patients who have used or possess this specific product should stop using it and contact Ivoclar Vivadent, Inc. for further instructions or a refund. The product is distributed worldwide, including the United States, Canada, and Australia.
The recalled product
- Product
- Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
- Manufacturer
- Ivoclar Vivadent, Inc.
- Hazard
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 (3)
- Lot No./Expiration Date: TL4095/Jan 15
- 2017
- TL4094/Jan 15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ivoclar Vivadent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ivoclar Vivadent, Inc.
See all →- HighDental amalgam powder may not triturate properly, affecting restoration strength
FDA (Devices) · 2024-02-14
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07