Summary
The FDA issued a Class II for AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. by Aesculap AG. Reason: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard.".
Details
Source
Device Recall
External ID
Z-0026-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Lot/Code Info: Model Number: BG942R, UDI-DI Number: 04046963805777. Serial Number: 8157.
Quantity Affected: 1 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."
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-18
Company
Tuttlingen, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap AG has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap AG have FDA actions?
Aesculap AG has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0026-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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