FDA recall Z-0027-2026

Product

AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

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."

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.

Key facts

Status

Ongoing

Initiation date

2025-08-18

Report date

2025-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tuttlingen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0027-2026