AESCULAP ELAN 4 FIXED DURAGUARD STANDARD — Class II medical device recall Z-0026-2026
Ongoing recall by Aesculap AG, reported 2025-10-08, distributed in MO. Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was
| Recall number | Z-0026-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap AG, Tuttlingen, N/A, Germany |
| Recall initiated | 2025-08-18 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Distributed | MO |
| Countries outside the US | BR, CL, CN, CZ, DE, FR, HK, ID, IN, IR, JP, MX, MY, NO, PH, PT, SA, TH, TR |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04046963805777 |
| Serial numbers | 8157 |
| Model numbers | BG942R, GB942R |
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0026-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.