Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0026-2026 · Posted 2025-10-02

Recalling FirmAesculap AG
Recall StatusOpen, Classified
Product CodeHBB
Date Initiated2025-08-18
Product Quantity1 unit

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."

Firm Action

Asculap notified consignees with an "Urgent Field Safety Notice" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter. If you have any question, call 484.240.8373 or email:[email protected].

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172907ELAN 4 Air Motor SystemAesculap, Inc. · 2018-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑