IPS Empress Universal Glaze Spray 270 mL — Class II medical device recall Z-2265-2015
Terminated recall by Ivoclar Vivadent, Inc., reported 2015-08-05, distributed in IA, IN, PA, SC. Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic co
| Recall number | Z-2265-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Buffalo, NY, United States |
| Recall initiated | 2015-07-09 |
| Classified | 2015-07-27 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2016-05-27 |
| Distributed | IA, IN, PA, SC |
| Quantity | 27 units |
| Reason classes | foreign material |
| Lot numbers | U15124 |
| Model numbers | 609432AN |
Product
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
Reason for recall
Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
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-2265-2015. 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.