Henry Schein Recalls Dental Composite Capsules Due to Incorrect Packaging
Henry Schein Inc. is recalling specific lots of Grandio Universal Nano-Hybrid Restorative Material capsules because they were distributed with incorrect packaging and Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves incorrect packaging and Instructions for Use, which aligns with the rubric criteria for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Henry Schein Inc. is recalling 853 units of Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm. The affected product is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures. The recall involves specific product codes and lot numbers, including 949-3594, 949-3595, 949-3596, and 949-3597.
The recall was initiated because specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. The agency classifies this as a Class II recall. The distribution pattern includes US Nationwide and the country of Barbados.
Dental professionals and consumers should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product matches the recalled lots, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Henry Schein Inc.
- Affected units
- 853
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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