Cook Incorporated: Medical Device Recall in 2025 - (Recall #: Z-0994-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 26, 2025

Date Posted: December 31, 2025

Recall Number: Z-0994-2026

Event ID: 98027

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.

Status: Ongoing

Product Quantity: 15 units

Code Information:

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 Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated