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Ivoclar Vivadent, Inc. Recalls

Overview of recall records associated with Ivoclar Vivadent, Inc., including dates, categories and classifications where available.

32recall records

Feb 14, 2024latest record date

Aug 5, 2015earliest record date

Recall history in this database

Classification mix: Class II: 28, Class III: 4.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color B4 60ml, art. no. 681058 recall — FDA Z-0029-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color B2 60ml, art. no. 681056 recall — FDA Z-0027-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color C1 60ml, art. no. 681059 recall — FDA Z-0030-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A3 60ml, art. no. 681052 recall — FDA Z-0023-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color C3 60ml, art. no. 681061 recall — FDA Z-0032-2017

The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceAug 17, 2016

Ivoclar Vivadent OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID recall — FDA Z-2373-2016

After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol,…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceMar 9, 2016

Ivoclar Vivadent Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art recall — FDA Z-1026-2016

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…

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceAug 5, 2015

Ivoclar Vivadent IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number recall — FDA Z-2265-2015

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.

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Ivoclar Vivadent, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.