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, PREGNANT, PETS
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
- Duraguard Surgical Instrument/Fixed Device
- Model numbers
- GB943R
- Colors
- Unknown
- Sizes
- Unknown
- 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 clinical settings for stabilization; mislabeling affects variant identification and usage.
Why This Is Dangerous
Labeling errors can cause healthcare providers to use the wrong configuration, potentially impacting intended outcomes.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Mislabeling could slow procedures or require retesting and re-education of staff; three units are affected.
Practical Guidance
How to identify if yours is affected
- Verify model GB943R.
- Check serial numbers 4519, 4528, 4533.
- Confirm labeling matches the correct Duraguard variant.
Where to find product info
Model GB943R and serial numbers appear on the device and accompanying packaging.
What timeline to expect
Recall process details not provided; expect manufacturer guidance via email within weeks.
If the manufacturer is unresponsive
- Contact healthcare provider for guidance.
- Reach out to Aesculap AG for instructions; document all communications.
How to prevent similar issues
- Double-check labeling during procurement.
- Maintain updated records of device labeling and serials.
- Follow manufacturer training for Duraguard variants.
Documentation advice
Keep recall emails, device labels, serial numbers, purchase records, and communications with the manufacturer.
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Product Details
Brand: Aesculap AG. Product: ELAN 4 Fixed Duraguard Long. Model number: GB943R. UDI-DI: 04046963805784. Serial numbers: 4519, 4528, 4533. Distribution: US to Missouri. International distribution to Norway, Portugal, France, Great Britain, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand. Status: Active recall. Recall date: 2025-08-18. Report date: 2025-10-08. Hazard: Mislabeling of long vs standard variants. Quantity: 3 units.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- GB943R mislabeling
- US distribution Missouri
- International list includes 18 countries
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Safety Guide
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