Grandio Universal Nano-Hybrid Restorative Material — Class II medical device recall Z-3016-2026
Ongoing recall by Henry Schein Inc., reported 2026-09-02, distributed nationwide. Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S.
| Recall number | Z-3016-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Henry Schein Inc., Denver, PA, United States |
| Recall initiated | 2026-07-09 |
| Classified | 2026-08-25 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB |
| Quantity | 853 units |
| Lot numbers | 2529604, 2535296, 2536632, 2537418, 2538147, 2539065, 2539075, 2539313, 2607283, 2608145, 2609174, 2609789, 2610099 |
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.
Reason for recall
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
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-3016-2026. 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.