Aesculap Elan 4 Fixed Duraguard Standard recall: Labeling Error
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Why was Aesculap Elan 4 Fixed Duraguard Standard 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- Recalling firm
- Aesculap AG
- Quantity
- 1 unit
- 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.
- Recall date
- October 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)