CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

R¿sch-Uchida Transjugular Liver Access Sets recalled

Cook is recalling R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: Rups-100. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065

Quantity recalled23 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0995-2026
FDA event ID: 98027
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 26 Nov 2025
FDA classified: 23 Dec 2025
Reported: 31 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

26 Nov 2025	Recall initiated by company
23 Dec 2025	Classified by FDA	+27 days
31 Dec 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98027

This product is part of a recall event; the main page for the event is Flexor Check-Flo Introducers and Sets, Reference Part recalled.

Reported	Class	Recall	Company	Reason	Where
31 Dec 2025	CLASS II	Flexor Check-Flo Introducers and Sets, Reference Part recalled	Cook	Potency & Assay	IN
31 Dec 2025	CLASS II	Ring Transjugular Intrahepatic Access Sets recalled by Cook Incorporated	Cook	Potency & Assay	IN

More recalls from Cook

All 349

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook	Other	IN

Other Test Kits & Diagnostics recalls

All 2,661

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide