Aesculap Surgical Instrument Mislabeled Standard and Long Models
The AESCULAP ELAN 4 FIXED DURAGUARD surgical instrument was mislabeled: Standard versions labeled as 'Long' and Long versions labeled as 'Standard.' The error affects units distributed to the US and multiple countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device with a labeling error and no reported illnesses or injuries. The rubric categorizes minor labeling errors as score 2 (Moderate).
Plain-English summary
The AESCULAP ELAN 4 FIXED DURAGUARD surgical instrument (Model GB942R) is being recalled due to mislabeling. The Standard version was labeled as 'Long,' and the Long version was labeled as 'Standard.'
The labeling error means surgical instruments will have incorrect size designations on their packaging. The affected units with Serial Number 8157 were distributed to the United States (Missouri) and internationally to Norway, Portugal, France, Great Britain, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, and Thailand.
Healthcare facilities and users should verify the actual size of their instruments against the labeling error described in this recall.
The recalled product
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
- Manufacturer
- Aesculap AG
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: BG942R
- UDI-DI Number: 04046963805777. Serial Number: 8157.
Distribution
Distribution scope not specified by the agency.
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