HIGH

Aesculap AG Recalls Surgical Instrument Due to Mislabeling

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.

Quick Facts at a Glance

Recall Date
August 18, 2025
Hazard Level
HIGH
Brand
Aesculap AG
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

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

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Product Details

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 Hazard

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.

Reported Incidents

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.

What to Do

Stop using the affected devices immediately. Contact Aesculap AG or your healthcare provider for further instructions on the recall process.

Contact Information

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.

Key Facts

  • Recall date: August 18, 2025
  • Model Number: GB943R
  • Quantity recalled: 3 units
  • Hazard: Mislabeling
  • Distribution: U.S. and multiple countries

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSurgical Instrument
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Number: GB943R
UDI-DI Number: 04046963805784. Serial Numbers: 4519
4528
4533.
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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