Henry Schein Inc. recalls Structur 2 SC Temporary Resin Cartridge Refill 75Gm

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

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.

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 accompanied the affected lot numbers. (4) Please complete, sign, date, and return the enclosed Henry Schein Response Form within thirty (30) calendar days of receipt to HSResponseForm@henryschein.com. OTHER INFORMATION: If you have any further questions regarding this matter, please contact Henry Schein Customer Service at 1-800-472-4346.

• FDA enforcement recordOfficial FDA database entry for Z-3015-2026
• FDA 510(k) clearance · K040769The device's official FDA premarket clearance record
• FDA device classification · EBFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3690The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Henry Schein Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.