Class II

Medical Device Recall: AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Aesculap AG · August 18, 2025

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."

Distribution

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.

Quantity Affected

3 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0027-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.