Z-3016-2026Class II

Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product...

Name: Z-3016-2026 Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product...
Creator: Henry Schein Inc.
Published: 2026-07-09
License: https://open.fda.gov/license/

Henry Schein, Inc. / initiated 2026-07-09 / Open, Classified / root cause: manufacturing process

FDA source

Henry Schein Inc. began a recall of Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2)... on 2026-07-09. FDA classified it as Class II and gives the reason as "Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3016-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-09
Posted: 2026-08-25
Recalling firm: Henry Schein, Inc.
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.
Product code: EBF Material, Tooth Shade, Resin
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. OTHER INFORMATION: If you have any further questions regarding this matter, please contact Henry Schein Customer Service at 1-800-472-4346.
Quantity in commerce: 853 units
Distribution: Worldwide distribution - US Nationwide and the country of Barbados.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3016-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3015-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-25
Z-3016-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-25

Product code EBF

K051867Class IIGrandioVoco GmbH / cleared 2005-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)