Recall archive
9 recalls · page 1 of 1
Reported Feb 14, 2024
Article No. NA6050411, Valiant PhD No. 1 Econo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression,…
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ivoclar Vivadent, Inc.
Matched: Brand — Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2016
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2016
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two…
FDA (openFDA device enforcement)
Reported Mar 9, 2016
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong…
FDA (openFDA device enforcement)
Reported Aug 5, 2015
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jun 18, 2014
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand — A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
FDA (openFDA device enforcement)
Reported Nov 27, 2013
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ivoclar Vivadent, Inc.
Matched: Brand · Reason for recall — Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with…
FDA (openFDA device enforcement)
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