Surgical guard attachments recalled after long and standard labels were swapped
Aesculap is recalling three ELAN 4 Fixed Duraguard Long units after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
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: Scored 2 under the labeling-error criterion: the notice describes swapped Long and Standard labels with no stated hazard or reported harm.
Plain-English summary
The AESCULAP ELAN 4 FIXED DURAGUARD LONG, model number GB943R, is being recalled for mislabeling. The ELAN 4 Fixed Duraguard Standard was labeled as "Long" and the ELAN 4 Fixed Duraguard Long was labeled as "Standard".
The recall covers three units, serial numbers 4519, 4528 and 4533, carrying UDI-DI 04046963805784. They were distributed to Missouri in the United States, with additional international distribution to Norway, Portugal, France, Great Britain and the Czech Republic. The FDA has classified the action as Class II.
The enforcement record describes the label swap and does not state any injury or clinical consequence. Facilities holding the affected serial numbers should verify the actual configuration rather than relying on the label, and follow the firm's instructions.
The recalled product
- Product
- AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
- Manufacturer
- Aesculap AG
- Hazard
- mislabeling
- wrong-configuration
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 (4)
- Model Number: GB943R
- UDI-DI Number: 04046963805784. Serial Numbers: 4519
- 4528
- 4533.
Distribution
Distribution scope not specified by the agency.
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