The Recall Desk
Severity pendingFDA (Devices)·Z-0994-2026·Announced 2025-12-31

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10

Pending LLM rewrite. Source: FDA_DEVICE Z-0994-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

Product
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.
Manufacturer
Cook Incorporated

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 (6)

  • 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

Distribution

Distribution scope not specified by the agency.