Reported Oct 12, 2016 · Terminated

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

Ivoclar Vivadent, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ivoclar Vivadent, Inc. · 175 Pineview Dr · Amherst, NY · 14228-2231

Is this the product you have?

    • Zenostar MT Color A3.5 60ml
    • art. no. 681053
  • Product UsageFor coloring dental porcelain
Lot codes and dates
  • Lot NoU49659
  • exp date
    • Nov 2 2017
    • U43928
  • exp date
    • Oct 19 2017
    • and U38672
  • exp dateSep 15 2017
Amount recalled
17 units

This recall covers 21 products

The agency filed one notice per product. You are reading one of them; the other 20 are below.

8 more are in the archive.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 14, 2018 · Data as of Sep 19, 6:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.