Ivoclar Vivadent Recalls Virtual XD Dental Impression Material
Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (failure to set) rather than a direct safety risk like infection or toxicity, fitting the criteria for a moderate severity rating.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling Virtual XD Refill Light Body Fast Set Wash Material, a dental impression material. The recall involves 4,659 units in the United States and 729 units in Canada, with distribution also reported in Australia.
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.
Affected lots include UL2395, UL2293, UL2222, UL2220, and TL4121. Consumers and dental professionals should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, 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 (7)
- Lot No./Expiration Date: UL2395/June 28
- 2018
- UL2293/Dec 31
- 2017
- UL2222/Aug 28
- UL2220/July 28
- TL4121/ Mar 28
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.
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