CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report
Ring Transjugular Intrahepatic Access Sets recalled by Cook Incorporated
Cook is recalling Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers:;.0. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class II.
Check your package
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-0994-2026
- 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
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.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
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 98027This 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 |
|---|---|---|---|---|---|
| CLASS II | Flexor Check-Flo Introducers and Sets, Reference Part recalled | Cook | Potency & Assay | IN | |
| CLASS II | R¿sch-Uchida Transjugular Liver Access Sets recalled | Cook | Potency & Assay | IN |
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