{"url_path":"/fda/device/recalls/Z-3016-2026","section_key":"summary","section_title":"DEVICE Recall: 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, 2607…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-09","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3016-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Henry Schein Inc."},"word_count":174,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3016-2026\n\n**Recalling firm:** Henry Schein Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-09\n**Report date:** 2026-09-02\n\n## Product\nGrandio 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.\n\n## Reason\nSpecific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.\n\n## Affected lots\nProduct 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.\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Barbados."}