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

FDA Recall #Z-0027-2026 — Class II — August 18, 2025

Recall #Z-0027-2026 Date: August 18, 2025 Classification: Class II Status: Ongoing

Product Description

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."

Recalling Firm

Aesculap AG — Tuttlingen, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 units

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.

Code Information

Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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