FDA issues warning about Olympus ligating devices after 113 injuries
The U.S. Food and Drug Administration (FDA) issued a recall on a line of Single Use Ligating Devices manufactured by Olympus after the agency said it became aware of a notice the company sent to customers. The products are used with an endoscope to control bleeding following the removal of pedunculated polyps. They typically detach after closing a wound.
The company said it received complaints about the devices failing to release as expected, causing them to become unintentionally anchored in place. Specifically, Olympus found that a nylon ligation loop could fail to release when the yellow tube joint is moved away from the handle or the handle’s slider is forcefully advanced despite resistance.
An unreleased ligation loop can create significant difficulties, sometimes requiring emergency intervention to remove the device safely. As a result of the loops becoming stuck, alternative removal methods would have to be deployed, greatly increasing the risk of serious complications, including severe tissue injury, bleeding and possibly death.
As of October 1, 2025, Olympus said it received reports of 113 serious injuries associated with the malfunction. No deaths have been confirmed. Given the severe risks associated with the nylon loops not releasing, the FDA has designated this recall a Class I, its most serious type.
Without following updated safety instructions, the agency warns the ligating polyloops can be deadly.
What’s being recalled?
The below devices are subject to this recall:
- Device Name: Single Use Ligating Device PolyLoop
- Model/Catalog Number: HX-400U-30
- Manufactured Date Range: September 22, 2022 – September 7, 2025
- UDI: 04953170368615
Next steps
On November 3, 2025 Olympus sent all known buyers of its Single Use Ligating PolyLoops a letter with a warning about the release issue, along with updated use instructions.
The company tells all users to always have a loop cutter available and to avoid moving the yellow tube joint away from the handle or forcefully advancing the slider if resistance is felt. This is the primary reason why the nylon fails to release.
If standard removal methods fail, patients are at serious risk of injury. The devices should be inspected before being used to ensure they release appropriately.
Those with more questions are asked to call Olympus at 1-800-848-9024, option 1.
The company and the FDA ask that the recall notice be shared. It can be found by clicking here.
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