Recall Z-3015-2026— Henry Schein Inc.

Name: FDA recall Z-3015-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Class II · Ongoing

Class II FDA medical device recall by Henry Schein Inc., initiated 2026-07-09. It names one FDA 510(k) clearance: K040769. Product: 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.. Reason: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device..

Recalling firm: Henry Schein Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-09
Firm location: Denver, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K040769 — STRUCTUR 2 SCVoco GmbH·cleared 2004-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.