Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IPS Empress Universal Glaze Spray 270 mL Recalled by Ivoclar Vivadent, Inc. Due to Complaints were received of coarse particles in the...

Date: July 9, 2015
Company: Ivoclar Vivadent, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ivoclar Vivadent, Inc. directly.

Affected Products

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

Quantity: Domestic: 27 units

Why Was This Recalled?

Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

Where Was This Sold?

This product was distributed to 4 states: IN, IA, PA, SC

Affected (4 states)Not affected

About Ivoclar Vivadent, Inc.

Ivoclar Vivadent, Inc. has 34 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report