Medical Device Recall: 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 253
Henry Schein Inc. · July 9, 2026
Reason for Recall
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Product Description
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.
Distribution
Worldwide distribution - US Nationwide and the country of Barbados.
States Affected
NATIONWIDE
Quantity Affected
853 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3016-2026
Status: ongoing
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