Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
Ivoclar Vivadent is recalling Virtual XD Refill Light Body 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. The hazard involves a functional defect (failure to set) rather than a direct safety risk like injury or illness, fitting the criteria for moderate severity.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml (Product Code 646462). This dental impression material is distributed in the United States, Canada, and Australia.
The recall was initiated after the firm received complaints that the dental material failed to set up. The source text notes that as the dental material ages, the set time may increase.
Affected units include 1,867 units in the US and 465 units in Canada. The specific lots involved are UL2221 (expiration date July 28, 2017) and TL4056 (expiration date November 28, 2016). Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, 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 (4)
- Lot No./Expiration Date: UL2221/July 28
- 2017
- TL4056/Nov 28
- 2016
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