Quick Facts at a Glance
- Recall Date
- August 18, 2025
- Hazard Level
- HIGH
- Brand
- Aesculap AG
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Aesculap AG
- Product type
- Elan 4 Fixed Duraguard
- Model numbers
- GB942R, BG942R
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 18, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aesculap AG or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The ELAN 4 Fixed Duraguard is a medical device used in surgical contexts requiring a fixed Duraguard configuration.
Why This Is Dangerous
Mislabeling between Long and Standard variants could lead to incorrect device selection during procedures.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Clinicians must verify device labeling to avoid incorrect instrument configuration; potential impact on procedure planning and patient safety.
Practical Guidance
How to identify if yours is affected
- Check device labeling for GB942R and alternate BG942R
- Verify against UDI-DI 04046963805777 and Serial Number 8157
- Compare labeling with documentation and packaging
Where to find product info
UDI label on packaging and device documentation; recall notice provides guidance
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks
If the manufacturer is unresponsive
- Escalate to regulatory bodies if the manufacturer is slow to respond
- Maintain records of all correspondence and recall notices
How to prevent similar issues
- Verify labeling accuracy during procurement
- Confirm UDI numbers and model during device selection
- Train staff to check for mislabeling before use
Documentation advice
Keep recall notices, emails, serial numbers, photos, and correspondence
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Product Details
Model: GB942R (also listed as BG942R in some records). Distribution: US to Missouri; International distribution to Norway, Portugal, France, United Kingdom, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand. Quantity: 1 unit. Sold/used date and price not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model GB942R / BG942R
- Distribution US (Missouri) and international markets
- Hazard: mislabeling between 'Long' and 'Standard'
- Status: Active recall as of 2025-10-08
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Safety Guide
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