Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
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
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The ELAN 4 Fixed Duraguard is a medical device used in clinical settings for stabilization; mislabeling affects variant identification and usage.
Labeling errors can cause healthcare providers to use the wrong configuration, potentially impacting intended outcomes.
This recall is not described as part of a broader industry pattern.
Mislabeling could slow procedures or require retesting and re-education of staff; three units are affected.
Model GB943R and serial numbers appear on the device and accompanying packaging.
Recall process details not provided; expect manufacturer guidance via email within weeks.
Keep recall emails, device labels, serial numbers, purchase records, and communications with the manufacturer.
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.
No injuries or incidents have been reported in the provided data.
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