Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. Recalled by Aesculap AG Due to Mislabeling

Date: August 18, 2025
Company: Aesculap AG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap AG directly.

Affected Products

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Quantity: 1 unit

Why Was This Recalled?

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

Where Was This Sold?

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.

About Aesculap AG

Aesculap AG has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report