Z-0570-2026Class I

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used...

Name: Z-0570-2026 Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used...
Creator: Olympus Corporation of the Americas
Published: 2025-10-30
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-30 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2025-10-30. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0570-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-30
Posted: 2025-11-25
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: MND Ligator, Esophageal
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.
Root cause tag: manufacturing process
FDA root 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. ***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
Quantity in commerce: 7803 units
Distribution: US-wide distribution
Product codes and lots: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-25

Product code MND

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)