Class II U.S. Food and Drug Administration

Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recall: Specific lots were distributed in the US with incorrect packaging

Recall published last month

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-3016-2026
Published
September 2, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Henry Schein Inc.
Product type
Medical devices
Units affected
853 units
Distribution
Nationwide
Made in
United States
Lot / code info
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.

Products covered by this recall

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.

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2529604
  • 2538147
  • 2608145 2
  • 2539075
  • 2539313
  • 2609789
  • 2539065 3
  • 2536632
  • 2609174
  • 2610099 4
  • 2535296
  • 2537418
  • 2607283
  • 2608145
  • 2539065
  • 2610099
  • 2607283. — 853 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 1840
  • 1841
  • 1842
  • 1843

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Henry Schein Inc. — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Henry Schein Inc. — 41 Weaver Rd, Denver, PA, 17517-9308

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Henry Schein Inc. medical devices recalled?

Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2529604, 2538147, 2608145 2; model number 1840, 1841, 1842. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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