Recall Z-0027-2026— Aesculap AG

Name: FDA recall Z-0027-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-18

Class II · Ongoing

Class II FDA medical device recall by Aesculap AG, initiated 2025-08-18. It names one FDA 510(k) clearance: K172907. Product: AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2025-08-18
Firm location: Tuttlingen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K172907 — ELAN 4 Air Motor SystemAesculap, Inc.·cleared 2018-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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."

Data sourced from openFDA. This site is unofficial and independent of the FDA.