Recall archive / FDA device enforcement
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an... — FDA record Z-0570-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 7803 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0570-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US-wide distribution
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 3, 2025
- Recall initiation date
- Oct 30, 2025
- Center classification date
- Nov 25, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.