# FDA recall Z-3016-2026

> **Henry Schein Inc.** · Class II · device recall initiated 2026-07-09.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the country of Barbados.

## Key facts

- **Recall number:** Z-3016-2026
- **Recalling firm:** Henry Schein Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-09
- **Report date:** 2026-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denver, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3016-2026

## Citation

> MORVS. FDA recall Z-3016-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3016-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*