FDAHealthAugust 18, 2025
Aesculap AG — AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
⚠️ Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- August 18, 2025
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.
What's affected?
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- Brand
- Aesculap AG
- Lot code
- Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
Additional details
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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