Class 1 Device Recall Single Use Ligating Device

• Date Initiated by Firm: October 30, 2025
• Date Posted: November 25, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0570-2026
• Recall Event ID: 97731
• Product Classification: Ligator, esophageal - Product Code MND
• Product: 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: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: 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 Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 7803 units
• Distribution: US-wide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.