Aesculap Elan 4 Duraguard (Aesculap) – Mislabeling Issue (2025)
Mislabeling may cause confusion but does not directly pose an immediate safety risk.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Brand
Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany
Lot Codes / Batch Numbers
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
Products Sold
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany is recalling AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. due to Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard.". Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO
Page updated: Jan 10, 2026