Z-0995-2026Class II

Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular...

Name: Z-0995-2026 Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular...
Creator: Cook Incorporated
Published: 2025-11-26
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2025-11-26 / Open, Classified / root cause: manufacturing process

FDA source

Cook Incorporated began a recall of Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver... on 2025-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0995-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-26
Posted: 2025-12-23
Recalling firm: Cook Incorporated
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 23 units
Distribution: Worldwide distribution.
Product codes and lots: Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0994-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23
Z-0995-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-23

Product code DYB

K171820Class IITransjugular Liver Access SetsCook Incorporated / cleared 2018-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)