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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 DeviceFeb 14, 2024

Ivoclar Vivadent Article No. NA6050411, Valiant PhD No. 1 Econo recall — FDA Z-1006-2024

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely…

Class IIFDA: OngoingIvoclar Vivadent, Inc.

Medical DeviceFeb 28, 2018

Ivoclar Vivadent Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number recall — FDA Z-0665-2018

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…

Class IIIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceFeb 28, 2018

Ivoclar Vivadent Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number recall — FDA Z-0666-2018

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…

Class IIIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceFeb 28, 2018

Ivoclar Vivadent Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number recall — FDA Z-0668-2018

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…

Class IIIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceFeb 28, 2018

Ivoclar Vivadent Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number recall — FDA Z-0667-2018

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and…

Class IIIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceDec 14, 2016

Ivoclar Vivadent Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code recall — FDA Z-0719-2017

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceDec 14, 2016

Ivoclar Vivadent Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF recall — FDA Z-0718-2017

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceDec 14, 2016

Ivoclar Vivadent Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product recall — FDA Z-0717-2017

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Class IIFDA: TerminatedIvoclar Vivadent, Inc.

Medical DeviceOct 12, 2016

Ivoclar Vivadent Zenostar MT Color A2 60ml, art. no. 681051 recall — FDA Z-0022-2017

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 A1 60ml, art. no. 681050, Product Usage: For coloring recall — FDA Z-0021-2017

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 Impulse orange, art. no. 681168 recall — FDA Z-0037-2017

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 D3 60ml, art. no. 681064 recall — FDA Z-0035-2017

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 C2 60ml art. no. 681060 recall — FDA Z-0031-2017

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 A3.5 60ml, art. no. 681053 recall — FDA Z-0024-2017

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 Impulse violet, art. no. 681166 Product Usage: For recall — FDA Z-0020-2017

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 D4 60ml, art. no. 681065 recall — FDA Z-0036-2017

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 Impulse blue, Art. no. 681165 Product Usage: For coloring recall — FDA Z-0017-2017

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 Impulse grey, art. no. 681167 Product Usage: For coloring recall — FDA Z-0019-2017

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 B3 60ml, art. no. 681057 recall — FDA Z-0028-2017

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 A4 60ml, art. no. 681054 recall — FDA Z-0025-2017

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 Impulse brown, art. no. 681169 Product Usage: For recall — FDA Z-0018-2017

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 B1 60ml, art. no. 681055 recall — FDA Z-0026-2017

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 C4 60ml, art. no. 681062 recall — FDA Z-0033-2017

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 D2 60ml, art. no. 681063 recall — FDA Z-0034-2017

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.

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.