Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm Recall
Announced 2026-09-02 · FDA
The FDA-recalled product is Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures. Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the US FDA-cleared device. The recall affects 853 units distributed worldwide, including the US and Barbados.
| Brand | 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. |
| Severity | moderate |
| Units affected | 121 |
| Distribution | Worldwide distribution - US Nationwide and the country of Barbados. |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Do not use any affected lots or product codes.
- Check if your product lot numbers match those listed in the recall and contact your dental provider or Henry Schein for guidance.
- Follow instructions from the FDA or manufacturer for return, replacement, or disposal of the affected product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.