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.
Reported: December 3, 2025 Initiated: October 30, 2025 #Z-0570-2026
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.
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 7803 units
- Distribution
- US-wide distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 7803 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Critical. Recall number: Z-0570-2026.
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