Henry Schein recalls specific Grandio Universal Nano-Hybrid Restorative Material capsules due to incorrect packaging and instructions from FDA-cleared devices. Affected lots include 949-3594 to 949-3597 with listed lot numbers.
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Henry Schein is recalling certain Grandio dental capsules because they were distributed with incorrect packaging and instructions for use. This could lead to improper application if users follow the wrong guidelines.
The capsules were distributed with incorrect packaging and instructions for use, which could lead to improper application if dental professionals follow the wrong guidelines. This is a labeling issue rather than a safety hazard in normal use.
Dentists and dental professionals who purchased the specific Grandio capsules with the listed product codes and lot numbers are affected. Those using the product without verifying the lot numbers are at higher risk of incorrect application.
Check the product code (949-3594 to 949-3597) and lot numbers (2529604, 2538147, 2608145, etc.) on the packaging. The product is a light-cured dental composite material for restorative procedures.
Verify the product code and lot numbers on the packaging to confirm if it is affected.
Henry Schein recalls Grandio Universal Nano-Hybrid Restorative Material capsules with product codes 949-3594 to 949-3597 and specific lot numbers.
Check the product code (949-3594 to 949-3597) and lot numbers (2529604, 2538147, 2608145, etc.) on the packaging.
The recall does not specify a remedy, so contact Henry Schein directly for guidance.
We’ve drafted a message you can send Henry Schein to request your refund or repair — edit it as you like.
Subject: Recall Z-3016-2026 — Henry Schein Henry Schein Hello, I own a Henry Schein that is covered by recall Z-3016-2026 from Henry Schein. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
