Class II — Henry Schein Inc.
| Recalling firm | HENRY SCHEIN, INC. |
|---|---|
| Registered facility | HENRY SCHEIN SERVICES GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| Product | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures. |
| Quantity | 853 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Barbados. |
| Initiated | 2026-07-09 |
| Classified | 2026-08-25 |
| Recall number | Z-3016-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Henry Schein Inc. (Z-3016-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99465/
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