Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19730
Brand Name:Ivoclar Vivadent Helioseal Clear
Model:
Affected:Batch: U30755
Software version:
Recalling Organisation:Ivoclar Vivadent Ltd
12 Omega Street
Albany
AUCKLAND
Contact Information:
Manufacturer:Ivoclar Vivadent AG
Issue:A wrong photo-initiator was used in the a production batch of product. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Healthcare Professional
Date Commenced:10/2/2016
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /