Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

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.

• FDA enforcement recordOfficial FDA database entry for Z-0027-2026
• FDA 510(k) clearance · K172907The device's official FDA premarket clearance record
• FDA device classification · HBBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Aesculap AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.