Ivoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles
Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.
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. The hazard involves coarse particles in dental restorations, which is a quality defect without reported serious injuries or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling IPS Empress Universal Glaze Spray 270 mL, Product Code 609432AN, Batch U15124. This product is a porcelain glaze spray used in the fabrication of dental restorations and is available by prescription only.
The recall was initiated after complaints were received regarding coarse particles in the glazed surface of IPS e.max Ceram restorations. The source text notes that a basic component of the glass contains a higher number of large grain sizes than usual.
The recall involves 27 units distributed in the United States in the states of Pennsylvania, Indiana, Iowa, and South Carolina. Consumers and dental professionals should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
- Manufacturer
- Ivoclar Vivadent, Inc.
- Affected units
- 27
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)
- Batch U15124
Distribution
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