Device recall
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.
- Recall number
- Z-3016-2026
- Event id
- 99465
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Henry Schein Inc.
- Report date
- Sep 2, 2026
- Posted
- Aug 25, 2026
- Initiated
- Jul 9, 2026
- Center classification date
- Aug 25, 2026
- Product code
- EBF
- Device type
- Material, Tooth Shade, Resin
- Reason
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Root cause
- Process control
- Quantity
- 853 units
- Code info
- Product Codes: 1) 949-3594, Mfr Product Code 1840, Lot Numbers: 2529604, 2538147, 2608145; 2) 949-3595, Mfr Product Code 1841, Lot Numbers: 2539075, 2539313, 2609789, 2539065; 3) 949-3596, Mfr Product Code 1842, Lot Numbers: 2536632, 2609174, 2610099; 4) 949-3597, Mfr Product Code 1843, Lot Numbers: 2535296, 2537418, 2607283.
- Distribution
- Worldwide distribution - US Nationwide and the country of Barbados.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K051867
- Location
- Denver, PA, United States