Aesculap AG recalled one unit of the ELAN 4 FIXED DURAGUARD STANDARD on August 18, 2025. The product was mislabeled, leading to potential use confusion. The recall affects distribution in the US and multiple international locations.
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
The recalled product is the ELAN 4 FIXED DURAGUARD STANDARD, Model Number GB942R. It was distributed in the US, specifically Missouri, and internationally to several countries including Norway, France, and Japan.
The mislabeling of the ELAN 4 FIXED DURAGUARD STANDARD could lead to incorrect usage. This poses a serious risk to patients if the wrong device is used in surgical procedures.
No incidents or injuries have been reported related to this recall. The potential for mislabeling creates a high-risk situation.
Patients and healthcare providers should stop using the device immediately. Contact Aesculap AG or your healthcare provider for further instructions.
For more information, contact Aesculap AG via email. Additional details can be found at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0026-2026.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.