Aesculap AG: Device Recall
Recall #Z-0027-2026 · 08/18/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0027-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Aesculap AG
- Status
- Ongoing
- Date Initiated
- 08/18/2025
- Location
- Tuttlingen, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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."
Product Description
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Distribution Pattern
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.
Other Recalls by Aesculap AG
- Class II: Risk 08/18/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.