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U.S. Department of Health and Human Services

Class 2 Device Recall Grandio

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 Class 2 Device Recall Grandiosee related information
Date Initiated by FirmJuly 09, 2026
Date PostedAugust 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3016-2026
Recall Event ID 99465
510(K)NumberK051867 
Product Classification Material, tooth shade, resin - Product Code EBF
ProductGrandio 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.
Code Information 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.
FEI Number 1000143438
Recalling Firm/
Manufacturer		 Henry Schein Inc.
41 Weaver Rd
Denver PA 17517-9308
For Additional Information ContactTracey Alexander
631-4543003
Manufacturer Reason
for Recall		Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
FDA Determined
Cause 2		Process control
ActionHenry Schein issue an URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION (Retail Level) notices to its consignees on 7/17/2026 via first class mail. The notices explained the issues concerning the packaging and instructions for use, risk to health, and requested the following actions be taken: (1) Review inventory to confirm if any of the affected lot numbers are in your possession. (2) If your facility has affected lots in inventory, please ensure you promptly provide the correct U.S. FDA-cleared IFU to all dental practitioners. (3) Destroy only the copies of the IFU that originally accompanied the affected lot numbers. (4) Please complete, sign, date, and return the enclosed Henry Schein Response Form within thirty (30) calendar days of receipt to HSResponseForm@henryschein.com. OTHER INFORMATION: If you have any further questions regarding this matter, please contact Henry Schein Customer Service at 1-800-472-4346.
Quantity in Commerce853 units
DistributionWorldwide distribution - US Nationwide and the country of Barbados.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EBF
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