Ivoclar Vivadent, Inc.
Complete recall history across all FDA and CPSC categories — 34 total recalls
Ivoclar Vivadent, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (34)
FDA medical device enforcement actions by Ivoclar Vivadent, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 21, 2023 | Article No. NA6050411, Valiant PhD No. 1 Econo | Affected product may not perform as expected; the amalgam powder may not trit... | Class II |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 | Complaints were filed claiming the material consistency was too soft and too ... | Class III |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 | Complaints were filed claiming the material consistency was too soft and too ... | Class III |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 | Complaints were filed claiming the material consistency was too soft and too ... | Class III |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Complaints were filed claiming the material consistency was too soft and too ... | Class III |
| Nov 9, 2016 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product C... | The firm received complaints claiming the dental material failed to set up. ... | Class II |
| Nov 9, 2016 | Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Produc... | The firm received complaints claiming the dental material failed to set up. ... | Class II |
| Nov 9, 2016 | Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 6464... | The firm received complaints claiming the dental material failed to set up. ... | Class II |
| Jul 11, 2016 | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 63... | After a few seconds of polishing with moderate force, parts of the OptraPol c... | Class II |
| May 27, 2016 | Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| May 27, 2016 | Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ... | The primary packaging of these products may show leaks in individual cases. A... | Class II |
| Feb 12, 2016 | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... | Complaints were received claiming the material failed to polymerize under the... | Class II |
| Jul 9, 2015 | IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 6... | Complaints were received of coarse particles in the glazed surface of IPS e.m... | Class II |
| Apr 14, 2014 | bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The access... | A stock check revealed broken glass fibers between the connector and the fibe... | Class II |
| Sep 23, 2013 | ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental a... | Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive fou... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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