FDA Medical Device Recalls (openFDA)
Aesculap AG: AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
- Recall number
- Z-0027-2026
- Recalling firm
- Aesculap AG
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
- Status
- Open, Classified
- Initiated
- 2025-08-18
- Posted
- 2025-10-02
- Terminated
- not on file
- 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
- 3 units
- 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, serial or model codes
- Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.
- 510(k) numbers
- ["K172907"]
- PMA numbers
- not on file
- Product code
- HBB
- Firm FEI
- 3002806315
- Firm city
- Tuttlingen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28