Tuttlingen, N/A, Germany
Aesculap AG recalls
1 recall recorded since 2018, most recently on 18 August 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 August 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0026-2026, Z-0027-2026
- AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.