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SINGLE USE LIGATING DEVICE recallZ-0570-2026 · Olympus Corporation of the Americas · initiated Oct 30, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On October 30, 2025 and again on November 3, 2025, URGENT: MEDICAL DEVICE CORRECTIVE ACTION letters were sent to customers. Actions to be taken: Users are reminded of the importance of adhering to the Warnings and Cautions statements that are present in the instructions for use (IFU, ref: GK4574 Rev 16). A diagram was provided to illustrate the need to maintain a straight position of the proximal end of the tube sheath to prevent increased frictional resistance which may lead to breakage of the operating piipe when the slider is pushed. Particular attention should be paid to the following key guidance within Sections 10 and 12 of the IFU. Carefully read the content of this letter, including the supplemental guidance and reinforced text from the IFU as noted above. a) Always have Olympus loop cutter available when using the PolyLoop device b) When operating the yellow tube joint (yellow cylinder), be careful not to move it away from the handle, prematurely tightening the loop which may cause the inability to release the ligation loop. c) If resistance is encountered, do not continue or force the advancement of the slider located on the device handle. 2. Ensure all personnel are completely knowledgeable on the content of this notification. You may continue to use the device and are reminded of the importance of adhering to the warnings that are present in the instructions for use. 3. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 4. If you have further distributed this product, identify your customers, and forward this notification to them. ***Update 04/24/2026*** On April 20, 2026 URGENT: MEDICAL DEVICE CORRECTIVE ACTION UPDATE letters were sent to customers. Olympus has updated the Instructions for Use (IFU) for the Single Use Ligating Device to clarify correct handling and loop-release techniques. The revised IFU includes previously issued guidance as well as supplemental explanations and illustrations intended to clari

Recall details

Recall number
Z-0570-2026
Status
Open, Classified
Initiated by the company
Oct 30, 2025
Posted by the FDA
Nov 25, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
7803 units
Product code
MND
Distribution
US-wide distribution

Product description

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

Code information (models, lots, serial numbers)

Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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