FDA-Device2026-09-02Class IIMISBRANDING
Henry Schein Grandio Universal dental composite recalled for incorrect packaging and instructions
What this means
Specific lots of Grandio Universal Nano-Hybrid Restorative Material (a dental composite used by dentists) were distributed with incorrect packaging and instructions for use. This affected 853 units across the US and Barbados. No injuries have been reported.
- If you are a dental professional, check your inventory against the lot numbers listed (949-3594, 949-3595, 949-3596, 949-3597).
- Do not use affected lots; contact your Henry Schein distributor for replacement product and correct instructions.
- Patients who received treatment with this material should contact their dentist with questions.
The agency's original wording
Hazard
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Barbados.
Affected count
853 units
Manufactured in
41 Weaver Rd, N/A, Denver, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3016-2026More Henry Schein recalls
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