Class II U.S. Food and Drug Administration

Henry Schein Inc. Structur 2 SC Temporary Resin Cartridge Refill 75Gm 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

This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

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-3015-2026
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
121 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Codes: 1) 114-3933, Mfr Product Code 1479, Lot Numbers: 2536179, 2606429; 2) 114-3934, Mfr Product Code 1480, Lot Numbers: 2539064; 3) 114-3935, Mfr Product Code 1481, Lot Numbers: 2533123; 4) 114-3937, Mfr Product Code 1482, Lot Numbers: 2533203, 2607170.

Products covered by this recall

Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.

Check your product

The notice names 14 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.

  • 2536179
  • 2606429 2
  • 2539064 3
  • 2533123 4
  • 2533203
  • 2606429
  • 2539064
  • 2533123
  • 2607170. — 121 units

Model or item number

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

  • ill 75Gm
  • 1479
  • 1480
  • 1481
  • 1482

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. — This is a packaging mix-up rather than a safety failure in the food itself — the wrong label, lid or sleeve went onto the product.

  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. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

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 2536179, 2606429 2, 2539064 3; model number ill 75Gm, 1479, 1480. 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?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

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