Olympus Corporation of the Americas recalled 7,803 units of the HX-400U-30 ligating device on October 30, 2025. The device may fail to release as intended, posing significant risks to patients. Healthcare providers must stop using the device immediately and follow recall instructions.
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Olympus HX-400U-30 ligating device, model number HX-400U-30. It was distributed across the United States and is classified as a Class I medical device.
The ligation loop may not detach as expected during procedures, which can result in it becoming unintentionally fixed around patient anatomy. This malfunction poses a serious risk of injury.
As of the recall date, there have been no reported injuries associated with this device. The potential for harm remains high due to the nature of the malfunction.
Patients and healthcare providers should immediately stop using the Olympus HX-400U-30 ligating device. Contact Olympus Corporation or your healthcare provider for specific instructions on how to proceed.
For more information, contact Olympus Corporation of the Americas at 1-800-XX-XXXX or visit their website at www.olympus.com.
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