Recall Z-3016-2026
Henry Schein Inc. · initiated July 9, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: 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.
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: Process control
Action taken
Henry 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.
Details
- Recall number
- Z-3016-2026
- Initiated
- July 9, 2026
- Posted by FDA
- August 25, 2026
- Product code
- EBF – Material, Tooth Shade, Resin
- Quantity
- 853 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Barbados.
- Recalling firm
- Henry Schein Inc., Denver, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3015-2026 Class II | Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the… | 07/09/2026Open, Classified |