Recall archive / FDA device enforcement
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac... — FDA record Z-0995-2026
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 Nov 26, 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
- R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
- Reason
- Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 23 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0995-2026
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 | Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 31, 2025
- Recall initiation date
- Nov 26, 2025
- Center classification date
- Dec 23, 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.