Aesculap Elan 4 Fixed Duraguard Surgical Devices Recalled for Mislabeling

Agency Publication Date: October 2, 2025

Summary

Aesculap AG is recalling four units of its Elan 4 Fixed Duraguard surgical devices because the products were labeled with the incorrect size. The "Standard" model (GB942R) was incorrectly labeled as "Long," and the "Long" model (GB943R) was incorrectly labeled as "Standard." This error involves one unit of the Standard model and three units of the Long model manufactured in Germany.

Risk

If a surgeon uses a mislabeled device, they may select the incorrect attachment length for a surgical procedure. This can lead to surgical complications, improper device fit, or delays while seeking the correct equipment.

What You Should Do

This recall involves the Aesculap Elan 4 Fixed Duraguard surgical devices, specifically the Standard model (Model GB942R/BG942R) and the Long model (Model GB943R).
Identify affected units by checking the serial numbers: for the Standard model, check for serial number 8157; for the Long model, check for serial numbers 4519, 4528, or 4533.
Stop using the recalled device immediately to avoid surgical errors.
Contact Aesculap AG or your distributor to arrange for the return, replacement, or correction of the mislabeled units.
For additional questions or to report issues, call the FDA at 1-888-463-6332.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AESCULAP ELAN 4 FIXED DURAGUARD STANDARD

Variants: Standard

Model / REF:

GB942R

BG942R

Serial Numbers:

8157

UDI:

04046963805777

Recall #: Z-0026-2026

Product: AESCULAP ELAN 4 FIXED DURAGUARD LONG

Variants: Long

Model / REF:

GB943R

Serial Numbers:

4519

4528

4533

UDI:

04046963805784

Recall #: Z-0027-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97507

Status: Active

Manufacturer: Aesculap AG

Sold By: Hospital distributors; Medical supply channels

Manufactured In: Germany

Units Affected: 2 products (1 unit; 3 units)

Distributed To: Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the Aesculap Elan 4 Fixed Duraguard surgical devices, specifically the Standard model (Model GB942R/BG942R) and the Long model (Model GB943R).

Identify affected units by checking the serial numbers: for the Standard model, check for serial number 8157; for the Long model, check for serial numbers 4519, 4528, or 4533.

Stop using the recalled device immediately to avoid surgical errors.

Contact Aesculap AG or your distributor to arrange for the return, replacement, or correction of the mislabeled units.

For additional questions or to report issues, call the FDA at 1-888-463-6332.