Recall Z-0995-2026
Cook Incorporated · initiated November 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Codes / lots: Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
Reason for recall
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.
FDA-determined cause: Process control
Action taken
Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/26/2025 by email and/or letter delivered via a courier. The notice explained the issue, risk to health, and requested the identification and return of the affected product. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Details
- Recall number
- Z-0995-2026
- Initiated
- November 26, 2025
- Posted by FDA
- December 23, 2025
- Product code
- DYB – Introducer, Catheter
- Quantity
- 23 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0993-2026 Class II | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | 11/26/2025Open, Classified |
| Z-0994-2026 Class II | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | 11/26/2025Open, Classified |