Olympus recalls HX-400U-30 single-use ligating devices due to potential for loops to become unintentionally fixed around patient anatomy during use. Affected units include all lots not expired.
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.
Olympus is recalling its HX-400U-30 single-use ligating devices because the nylon loop might not release properly during surgery, potentially causing injury. This is a serious risk for medical professionals using the device in procedures.
The ligating device's nylon loop may fail to release or detach as intended during use. This can cause the loop to become unintentionally fixed around patient anatomy, potentially leading to injury or complications during surgery.
Medical professionals who use the Olympus HX-400U-30 ligating device during procedures are most at risk. Patients undergoing surgery with this device could face injury if the loop becomes unintentionally fixed.
Check for the model number HX-400U-30 on the device. The product is used with an Olympus endoscope to deliver a nylon loop snare. All lots not expired are affected.
Immediately stop using the Olympus HX-400U-30 ligating device if you have it.
No, Olympus has recalled the HX-400U-30 due to a risk of the loop becoming unintentionally fixed around patient anatomy during use.
Look for the model number HX-400U-30 on the device, which is used with an Olympus endoscope to deliver a nylon loop snare.
Immediately stop using it now and contact Olympus for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0570-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0570-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
