AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Reported: October 8, 2025 Initiated: August 18, 2025 #Z-0026-2026
Product Description
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."
Details
- Recalling Firm
- Aesculap AG
- Units 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, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.
- Location
- Tuttlingen, N/A
Frequently Asked Questions
What product was recalled? ▼
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.. Recalled by Aesculap AG. Units affected: 1 unit.
Why was this product recalled? ▼
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 8, 2025. Severity: Moderate. Recall number: Z-0026-2026.
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