FDAFDA · Food and drugs·Recall number Z-0026-2026
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Published October 8, 2025 · Recall initiated: August 18, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Aesculap AG
- Distributor
- 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.
- Lot
- Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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