Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:36688
Brand Name:Ivoclar Vivadent Ltd - Ivoclar Vivadent AG Dental bonding
Model:Adhese 2 DC VivaPen Kit 2ml/100 and DC Cannulas for VivaPen / 100
Affected:Lots - Z0BRVD, Z0BSTG, Z0BR7Z, Z0BRVD and Z0BKPJ, Z0BKPK, Z0BNFX, Z0BP64
Software version:
Recalling Organisation:Ivoclar Vivadent Ltd
12 Omega Street
Albany
AUCKLAND
Contact Information:
Manufacturer:Ivoclar Vivadent AG
Issue:The manufacturer has identified a potential safety risk in the Adhese 2 DC product, specifically the blue DC Cannulas. During additional
quality testing, an unexpected variation in the amount of activator on some cannulas was observed. Depending on the individual clinical situation, this amount may result in reduced bonding of the restoration to the tooth structure and a potential loss of the restoration.
The problem relates exclusively to the blue DC cannulas. Therefore, the Adhese 2 product can be used without problem in light-curing mode using the black cannulas or with the single dose brushes in self-curing mode.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Healthcare Professional
Date Commenced:26/3/2026
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