{"recall":{"id":"fda-device-99465","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Henry Schein Inc. recalls 2 products","firm":"Henry Schein Inc.","date":"2026-07-09","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"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 temporary crowns, bridges, inlays and onlays.","code":"Product 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.","quantity":"121 units","number":"Z-3015-2026","classification":"Class II"},{"name":"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.","code":"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.","quantity":"853 units","number":"Z-3016-2026","classification":"Class II"}],"reason":"Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Barbados.","nationwide":true,"states":[],"units":"121 units; 853 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99465","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3efebcefb34b3451","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99465","record":[{"status":"Ongoing","city":"Denver","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99465","recalling_firm":"Henry Schein Inc.","address_1":"41 Weaver Rd","address_2":"N/A","postal_code":"17517-9308","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Barbados.","recall_number":"Z-3015-2026","product_description":"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 temporary crowns, bridges, inlays and onlays.","product_quantity":"121 units","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.","recall_initiation_date":"20260709","center_classification_date":"20260825","report_date":"20260902","code_info":"Product 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."},{"status":"Ongoing","city":"Denver","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99465","recalling_firm":"Henry Schein Inc.","address_1":"41 Weaver Rd","address_2":"N/A","postal_code":"17517-9308","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Barbados.","recall_number":"Z-3016-2026","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.","product_quantity":"853 units","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.","recall_initiation_date":"20260709","center_classification_date":"20260825","report_date":"20260902","code_info":"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."}]}}