Recall Z-3016-2026 ยท EBF Material, Tooth Shade, Resin
Henry Schein Inc.
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
| Date | Aug 25, 2026 (initiated Jul 9, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Henry Schein issue an URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION (Retail Level) notices to its consignees on 7/17/2026 via first class mail. The notices explained the issues concerning the packaging and instructions for use, risk to health, and requested the following actions be taken: (1) Review inventory to confirm if any of the affected lot numbers are in your possession. (2) If your facility has affected lots in inventory, please ensure you promptly provide the correct U.S. FDA-cleared IFU to all dental practitioners. (3) Destroy only the copies of the IFU that originally accompanie |
| Quantity | 853 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051867 | GRANDIO Voco GmbH, Jul 27, 2005 |