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Ivoclar Vivadent Recalls
34 recalls on record · November 27, 2013 to February 14, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 9, 2016Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Pr
Hazard: Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
August 5, 2015Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray u
Hazard: 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.
June 18, 2014Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessor
Hazard: A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
November 27, 2013Medical DevicesFDA
Ivoclar Vivadent, Inc. recalls ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Hazard: 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 cements.