Grandio Universal Nano-Hybrid Restorative Material recall
Henry Schein Inc. recalled Grandio Universal Nano-Hybrid Restorative Material on September 2, 2026 because of specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. It was sold nationwide.
Why it was recalled
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
What's recalled
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
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Henry Schein Inc., Denver, PA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide distribution - US Nationwide and the country of Barbados. - Status
- Ongoing
- Recall number
- Z-3016-2026
- Source
- U.S. Food and Drug Administration
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