Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0995-2026·Announced 2025-12-31

Transjugular liver access sets recalled over products manufactured out of specification

Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites out of specification manufacturing with no stated consequence or reported harm.

Plain-English summary

Rosch-Uchida Transjugular Liver Access Sets, reference part number RUPS-100, are being recalled by Cook Incorporated. The set is intended for transjugular liver access in diagnostic and interventional procedures.

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.

The record lists 23 units, including order number G06929 under UDI (01)00827002069299 from lot 16659065. Distribution was worldwide. The FDA has classified the action as Class II.

The record describes a manufacturing specification deviation and states no consequence or reported injuries. Facilities should quarantine affected lots and follow Cook's instructions.

The recalled product

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.
Manufacturer: Cook Incorporated
Category: Medical Device — Access set
Hazard: out-of-specification
incorrect-length
inspection-failure
Affected units: 23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Reference Part Number RUPS-100: Order Number G06929
UDI (01)00827002069299(17)280624(10)16659065
Lot Number 16659065

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Moderate
Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
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Critical
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Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
Cook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · out of specification