FDA-Device2025-12-03Class IPROCESSING DEFECT
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.
Hazard
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US-wide distribution
Affected count
7803 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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