Henry Schein Inc.: Material, Tooth Shade, Resin
Recall Summary Henry Schein Inc. is recalling specific lots of Grandio Universal Nano-Hybrid Restorative Material (a dental filling material) because they were distributed with incorrect packaging and instructions for use. The affected products were sold nationwide across the U.S. and in Barbados. Dentists and dental offices that received these specific lot numbers should identify them by their product codes and lot numbers.
- Recalling firm
- Henry Schein Inc.
- 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
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Barbados.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/635e4cef-0774-4a1f-9ed4-33183cd4043e