thejoe Ivoclar Vivadent, Inc.

Ivoclar Vivadent, Inc.: 34 FDA recall reports

Every medical device recall the FDA has published for Ivoclar Vivadent, Inc.. The fault, and how the agency graded it.

34Reports

0Class I

1Ongoing

2024-02-14Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	30
Class III	4

By year reported

Year	Reports
2013	1
2014	1
2015	1
2016	26
2018	4
2024	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Article No. NA6050411, Valiant PhD No. 1 Econo

Z-1006-2024 · Class II · reported 2024-02-14 · Ongoing

Why it was recalled: 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 affected.
Product: Article No. NA6050411, Valiant PhD No. 1 Econo
Where it went: US Nationwide distribution in the states IN and TN.
How much: 2 boxes (500 per box)

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Z-0665-2018 · Class III · reported 2018-02-28 · Terminated

Why it was recalled: 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 contouring.
Product: Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Where it went: US and Canada
How much: 2,153 units

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Z-0666-2018 · Class III · reported 2018-02-28 · Terminated

Why it was recalled: 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 contouring.
Product: Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Where it went: US and Canada
How much: 3,255 units

Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Z-0668-2018 · Class III · reported 2018-02-28 · Terminated

Why it was recalled: 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 contouring.
Product: Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Where it went: US and Canada
How much: 2 units

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Z-0667-2018 · Class III · reported 2018-02-28 · Terminated

Why it was recalled: 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 contouring.
Product: Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Where it went: US and Canada
How much: 1,244 units

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage:

Z-0719-2017 · Class II · reported 2016-12-14 · Terminated

Why it was recalled: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Product: Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Where it went: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
How much: US: 2090 units, Canada: 331 units, Australia: 465 units

Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Pro

Z-0718-2017 · Class II · reported 2016-12-14 · Terminated

Why it was recalled: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Product: Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Where it went: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
How much: US: 1867 units, Canada: 465 units

Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product

Z-0717-2017 · Class II · reported 2016-12-14 · Terminated

Why it was recalled: The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Product: Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Where it went: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
How much: US: 4659 units, Canada: 729 units

Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

Z-0022-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 72 units

Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Z-0021-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 94 units

Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

Z-0037-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 5 units

Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

Z-0035-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 18 units

Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

Z-0031-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 19 units

Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain

Z-0024-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 17 units

Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Z-0020-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 25 units

Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain

Z-0036-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 9 units

Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain

Z-0017-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 79 units

Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

Z-0019-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 60 units

Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

Z-0028-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 27 units

Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain

Z-0025-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 11 units

Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

Z-0018-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 11 units

Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain

Z-0026-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 43 units

Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain

Z-0033-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 10 units

Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

Z-0034-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 40 units

Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain

Z-0029-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 7 units

Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain

Z-0027-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 15 units

Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain

Z-0030-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 37 units

Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain

Z-0023-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 42 units

Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain

Z-0032-2017 · Class II · reported 2016-10-12 · Terminated

Why it was recalled: 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 irritation.
Product: Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Where it went: US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
How much: 13 units

OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame

Z-2373-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: 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, claiming that the abrasive polishers wear faster than expected.
Product: OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
Where it went: Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
How much: US: 86 units total

Showing the 30 most recent of 34. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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