Class II U.S. Food and Drug Administration

Aesculap Elan 4 Fixed Duraguard Long recall: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long"

Recall published 1+ years ago

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

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: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

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-0027-2026
Published
October 8, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Aesculap AG
Product type
Medical devices
Units affected
3 units
Distribution
Missouri
Made in
Germany
Lot / code info
Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.

Products covered by this recall

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Serial number

On the rating plate, often next to the date of manufacture.

  • 4519
  • 4528
  • 4533. — 3 units

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

Aesculap AG — 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. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  3. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  4. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.

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: Aesculap AG — Am Aesculap-Platz 1, Tuttlingen

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 Aesculap AG medical devices recalled?

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

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.

Which states were affected?

The notice lists Missouri.

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