Henry Schein Grandio Dental Capsules Recall: Incorrect Packaging Hazard
Henry Schein recalls specific Grandio Universal Nano-Hybrid Restorative Material capsules due to incorrect packaging and instructions from FDA-cleared devices. Affected lots include 949-3594 to 949-3597 with listed lot numbers.
Lower-risk recall
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
What happened, in plain English
Henry Schein is recalling certain Grandio dental capsules because they were distributed with incorrect packaging and instructions for use. This could lead to improper application if users follow the wrong guidelines. Read more at govinfonow.com/recall/697925-henry-schein-grandio-dental-capsules-recall-incorrect-packaging-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/697925-henry-schein-grandio-dental-capsules-recall-incorrect-packaging-hazard · Updated September 14, 2026 · FDA enforcement record: FDA #Z-3016-2026
Cite this page
“Henry Schein Grandio Dental Capsules Recall: Incorrect Packaging Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697925-henry-schein-grandio-dental-capsules-recall-incorrect-packaging-hazard. Based on FDA recall #Z-3016-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3016-2026%22&limit=1).
Why it’s dangerous
The capsules were distributed with incorrect packaging and instructions for use, which could lead to improper application if dental professionals follow the wrong guidelines. This is a labeling issue rather than a safety hazard in normal use.
Who’s affected
Dentists and dental professionals who purchased the specific Grandio capsules with the listed product codes and lot numbers are affected. Those using the product without verifying the lot numbers are at higher risk of incorrect application.
How to tell if you have this one
Check the product code (949-3594 to 949-3597) and lot numbers (2529604, 2538147, 2608145, etc.) on the packaging. The product is a light-cured dental composite material for restorative procedures.
- Brand
Henry Schein- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the country of Barbados.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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.; 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. | 121 units |
| Z-3016-2026 | 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 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. | 853 units |
What to do — step by step
Check Product Details
Verify the product code and lot numbers on the packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the country of Barbados.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3016-2026 (July 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3016-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.