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Correction Alert: Olympus Updates Use Instructions for Ligating Device
The FDA is aware that Olympus has issued a letter notifying affected customers that certain Single Use Ligating Devices have updated use instructions. Olympus received complaints of the ligation loop not releasing or detaching as expected during use, causing it to become unintentionally anchored in place. An unreleased ligation loop presents procedural challenges as emergency intervention may be required to remove the device from the patient, and the method used for removal significantly influences the severity of these risks.
As of October 1, 2025, Olympus has reported 113 serious injuries, and no deaths associated with this issue.
This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Olympus at 1-800-848-9024, and select option 1.
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