The Recall Desk

FDA (Devices) recall action 98027

Cook Incorporated recalled 3 products on 2025-12-31

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-12-31
Critical
0
Units
7,990

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2025-12-31

    Transjugular access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-12-31

    Transjugular liver access sets recalled over products manufactured out of specification

    Cook Incorporated is recalling 23 Rosch-Uchida Transjugular Liver Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    Product
    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-12-31

    Check-Flo introducers recalled over products manufactured out of specification

    Cook Incorporated is recalling 7,952 Flexor Check-Flo Introducers and Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.

    Product
    Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) K
    Category
    Distribution
    0 states