Cook Incorporated recalls Ring Transjugular Intrahepatic Access Sets
- Recalling company
- Cook Incorporated
- Product
- Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic 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 – may cause temporary or medically reversible health consequences
- Recall date
- Nov 26, 2025
- Reported
- Dec 31, 2025
- Distribution
- Worldwide distribution.
- Status
- Ongoing
- Quantity
- 15 units
- Lot / codes
- 1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779; 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
- Company location
- Bloomington, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0994-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0994-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.