FDA Medical devices recall ·
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R recall
- Recall number
- Z-0026-2026
- Date
- (initiated August 18, 2025)
- Company / brand
- Aesculap AG
Am Aesculap-Platz 1, Tuttlingen, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Why was it recalled?
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
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.
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0026-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.