Drug recall
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
FDA recall event 97507 · Class II · Aesculap AG
Key facts
| Event ID | 97507 |
|---|---|
| Recall numbers | Z-0026-2026, Z-0027-2026 |
| Recalling firm | Aesculap AG |
| Product type | Devices |
| Products | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R., AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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." |
| Initiation date | Aug 18, 2025 |
| Report date | Oct 8, 2025 |
| City | Tuttlingen |
| Country | Germany |
| FEI number | 3002806315 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: