AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
This recall is currently active, issued October 2, 2025. It was issued by Aesculap Ag Am Aesculap-Platz 1 Tuttlingen Germany.
- Recall Initiated
- August 18, 2025
- Posted
- October 2, 2025
- Recall Number
- Z-0027-2026
- Quantity
- 3 units
- Official Source
- View on FDA website ↗
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."
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.
Lot / Code Info
Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.
Root Cause
Process control
Action Taken
Asculap notified consignees with an "Urgent Field Safety Notice" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter. If you have any question, call 484.240.8373 or email:allison.longenhagen@bbraunusa.com.