FDA (Devices) recall action 74320

Ivoclar Vivadent, Inc. recalled 21 products on 2016-10-12

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2016-10-12
Critical: 0
Units: 654

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–21 of 21

ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3.5 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 17 units of Zenostar MT Color A3.5 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Brown Dental Porcelain
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color Impulse brown dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Blue Dental Porcelain
Ivoclar Vivadent is recalling 79 units of Zenostar MT Color Impulse blue dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 13 units of Zenostar MT Color C3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B3 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 27 units of Zenostar MT Color B3 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 15 units of Zenostar MT Color B2 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 43 units of Zenostar MT Color B1 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 18 units of Zenostar MT Color D3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 9 units of Zenostar MT Color D4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C4 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 10 units of Zenostar MT Color C4 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A3 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 42 units of Zenostar MT Color A3 dental porcelain coloring liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 40 units of Zenostar MT Color D2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A2 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain
Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks
Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Category
Distribution
31 states
ModerateFDA (Devices)··2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Grey Dental Porcelain
Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Category
Distribution
31 states