Class II U.S. Food and Drug Administration

Cook Incorporated Ring Transjugular Intrahepatic Access Sets recall: Cook Medical identified that products supplied in the affected device lots

Recall published 10 months ago

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 hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: 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.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0994-2026
Published
December 31, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cook Incorporated
Product type
Medical devices
Units affected
15 units
Made in
United States
Lot / code info
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
UPC codes
00827002065413, 00827002297692

Products covered by this recall

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.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00827002065413
  • 00827002297692

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 16705779
  • 16659044 — 15 units

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Cook Incorporated — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  3. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  4. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Cook Incorporated — 750 N Daniels Way, Bloomington, IN, 47404-9120

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cook Incorporated medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00827002065413, 00827002297692; lot code 16705779, 16659044 — 15 units. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

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