Zenostar MT Color Impulse grey — Class II medical device recall Z-0019-2017
Terminated recall by Ivoclar Vivadent, Inc., reported 2016-10-12, distributed nationwide. The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may e
| Recall number | Z-0019-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Amherst, NY, United States |
| Recall initiated | 2016-05-27 |
| Classified | 2016-10-04 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2018-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 60 units |
| Reason classes | packaging |
| Lot numbers | U39255, U44397, U52107, U52159 |
| Expiration dates | 2017-09-20, 2017-10-19, 2017-11-16, 2018-03-30 |
Product
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0019-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.