AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA Recall Z-0027-2026 · Posted 2025-10-02
Recalling FirmAesculap AG
Recall StatusOpen, Classified
Product CodeHBB
Date Initiated2025-08-18
Product Quantity3 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."
Firm Action
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:[email protected].
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.