{"url_path":"/fda/device/recalls/Z-3015-2026","section_key":"summary","section_title":"DEVICE Recall: Henry Schein Inc. — Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes:    1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429   2) 114-3934, Mfr Product Code 1480; Lot 2539064  3) 114-3935, Mfr Product Code 1481; Lot 2533123  4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of t…","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-3015-2026%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":164,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3015-2026\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\nStructur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes:    1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429   2) 114-3934, Mfr Product Code 1480; Lot 2539064  3) 114-3935, Mfr Product Code 1481; Lot 2533123  4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.\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) 114-3933, Mfr Product Code 1479, Lot Numbers:  2536179, 2606429;  2) 114-3934, Mfr Product Code 1480, Lot Numbers:  2539064;  3) 114-3935, Mfr Product Code 1481, Lot Numbers:  2533123;  4) 114-3937, Mfr Product Code 1482, Lot Numbers:  2533203, 2607170.\n\n## Distribution\nWorldwide distribution - US Nationwide and the country of Barbados."}