DeviceSignal · Recall classified
Henry Schein Inc.
FDA classified a device recall on 2026-08-25 · Class II · Z-3016-2026
EventRecall classified
Effective2026-08-25
ClassificationClass II
On 2026-08-25 the FDA classified a device recall from Henry Schein Inc. as Class II. Product: Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes…. Recall Z-3016-2026. The firm initiated it on 2026-07-09. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3016-2026
- Classification
- Class II
- Classified on
- 2026-08-25
- Initiated on
- 2026-07-09
- Firm
- Henry Schein Inc.
- Reason
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3016-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
6ef0c8fb998506d065e4f7df8bc5add91b2bfe65520b91d5f324a530ca998ca2- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)