Henry Schein Grandio Universal Nano-Hybrid Restorative Material Recall Over Incorrect Packaging
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Henry Schein Inc. is recalling 853 units of Grandio Universal Nano-Hybrid Restorative Material distributed with incorrect packaging and Instructions for Use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.", distributed worldwide distribution - us nationwide and the country of barbados.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Dental Devices.
What Happened
Specific lots of Grandio Universal Nano-Hybrid Restorative Material were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Which Products Are Affected
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm. Affected are:
- Product Code 949-3594 (Mfr 1840), Lots 2529604, 2538147, 2608145
- Product Code 949-3595 (Mfr 1841), Lots 2539075, 2539313, 2609789, 2539065
- Product Code 949-3596 (Mfr 1842), Lots 2536632, 2609174, 2610099
- Product Code 949-3597 (Mfr 1843), Lots 2535296, 2537418, 2607283 853 units distributed nationwide in the US and to Barbados.
What You Should Do
Verify lot numbers against the recalled list and do not use affected units.
Why This Matters
This Class II recall involves a light-cured dental composite material distributed with incorrect labeling that could affect proper use.
Source
FDA recall number Z-3016-2026
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (955 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.