FDA Enforcement
Class II
Ongoing
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Recall: Z-0026-2026
·
Reported October 8, 2025
Enforcement
- Recall Number
- Z-0026-2026
- Event ID
- 97507
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aesculap AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- October 8, 2025
- Initiation Date
- August 18, 2025
- Classification Date
- October 2, 2025
- Address
- Am Aesculap-Platz 1, N/A, Tuttlingen, N/A, N/A, Germany
Description
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Reason
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Code Info
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
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
1 unit