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Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Recalled October 8, 2025 · FDA recall Z-0026-2026 · Aesculap AG
Hazard
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard." · FDA Class II
Units
1 unit
Sold at
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.
Description
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Manufacturer(s)
Aesculap AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →