AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
FDA device recall Z-0026-2026 · posted 2025-10-02 · Open, Classified
Recall details
- Recalling firm
- Aesculap AG
- 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."
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBB
- Quantity affected
- 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,
- Date initiated
- 2025-08-18
- Date posted
- 2025-10-02
- Location
- Tuttlingen, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELAN 4 Air Motor System (K172907) | Aesculap, Inc. | 2018-11-09 |