The Recall Desk

Manufacturer

Cook Medical Incorporated

53 recalls in our database name Cook Medical Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
53
Critical
2
Severe
1
Most recent
2025-10-22

Of the 53 recalls from Cook Medical Incorporated we have scored against our rubric, 2 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–53 of 53

  • CriticalFDA (Devices)·Z-2099-2017·2017-08-16

    Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts

    Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.

    Product
    Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0689-2016·2016-02-03

    Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems

    Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.

    Product
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2015·2014-11-05

    Cook Medical Recalls Spirotome Soft-Tissue Biopsy Needle Sets

    Cook Medical is voluntarily recalling Spirotome Soft-Tissue Biopsy Needle Sets because protective caps may have dislodged inside the packaging.

    Product
    Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotom
    Category
    Medical Device
    Distribution
    Distributed nationwide