FDA Device recall Z-0026-2026
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R by Aesculap Ag, citing mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard.".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0026-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-18 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aesculap Ag |
| Distribution | MO |
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Reason
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Identifiers
| code_info | Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0026-2026%22
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