FDAFDA · Food and drugs·Recall number Z-3015-2026
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.
Published September 2, 2026 · Recall initiated: July 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Henry Schein Inc.
- Distributor
- Worldwide distribution - US Nationwide and the country of Barbados.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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