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.

26–50 of 53

  • ModerateFDA (Devices)·Z-0315-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0348-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0345-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0333-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0351-2019·2018-11-07

    Cook Medical Recalls Zilver Biliary Stent Due to Incorrect Removal Instructions

    Cook Medical is recalling 9,834 Zilver Biliary 518 Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0334-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0352-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,384 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0336-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0339-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0342-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0350-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0329-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0337-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0343-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0349-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0321-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide