Aesculap AG recalled three surgical instruments on August 18, 2025, due to mislabeling issues. The ELAN 4 FIXED DURAGUARD LONG was incorrectly labeled as "Standard" and vice versa. The recall affects devices distributed in the U.S. and several international markets.
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 AESCULAP ELAN 4 FIXED DURAGUARD LONG, Model Number: GB943R. It was distributed in the U.S. and internationally, including countries such as Norway and Brazil. The quantity recalled is three units.
The mislabeling of these devices poses a risk to patients and healthcare providers. Incorrect labeling could lead to the use of the wrong surgical instrument, potentially resulting in improper medical procedures.
As of the date of this recall, there are no reported incidents or injuries associated with this mislabeling. However, the potential risks warrant immediate action from users.
Stop using the affected devices immediately. Contact Aesculap AG or your healthcare provider for further instructions on the recall process.
For more information, visit Aesculap AG's recall page or contact them via email. Additional details can be found at the FDA's enforcement report.
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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.