Brand Name: Single Use Ligating Device Product Name recall
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…
Why was Brand Name: Single Use Ligating Device Product Name 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;
- 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…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 7803 units
- Distribution
- US-wide distribution
- Recall date
- December 3, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)