Recall Z-0026-2026 ยท HBB Motor, Drill, Pneumatic
Aesculap AG
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
| Date | Oct 2, 2025 (initiated Aug 18, 2025) |
| Status | Open, Classified |
| Reason | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." |
| Root cause | Process control |
| 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:allison.longenhagen@bbraunusa.com. |
| Quantity | 1 unit |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172907 | ELAN 4 Air Motor System Aesculap, Inc., Nov 9, 2018 |