FDA recall, , Moderate risk
Henry Schein Structur 2 SC and Grandio Restorative Materials
Structur 2 SC Temporary Resin Cartridge Refill was distributed with incorrect packaging and instructions.
Summary by Recall Canary from the FDA notice
What happened
Henry Schein Inc. of Denver, Pennsylvania, began a recall on July 9, 2026, of Structur 2 SC Temporary Resin Cartridge Refill and Grandio Universal Nano-Hybrid Restorative Material because specific lots were distributed in the US with incorrect packaging and Instructions for Use from the U.S. FDA-cleared device.
The FDA added the recall to its Enforcement Report and classified it on August 25, 2026. Distribution was worldwide, including the US nationwide and Barbados. The recall covers 121 units of Structur 2 SC and 853 units of Grandio Universal.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the list below, then check the codes the FDA notice also names.
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes
- Lot code
- 2529604
- 2538147
- 2608145
- 2539075
- 2539313
- 2609789
- 2539065
- 2536632
- 2609174
- 2610099
- 2535296
- 2537418
- 2607283
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes
- Lot code
- 2536179
- 2606429
- 2539064
- 2533123
- 2533203
- 2607170
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Barbados.
- Company
- Henry Schein Inc.Denver, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99465
- Recall numbers
- Z-3015-2026 to Z-3016-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
