Aesculap AG: Medical Device Recall in 2025 - (Recall #: Z-0027-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 18, 2025

Date Posted: October 8, 2025

Recall Number: Z-0027-2026

Event ID: 97507

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3 units

Code Information:

Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.

Distribution Pattern:

US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated