The Recall Desk

Manufacturer

Cook, Inc.

264 recalls in our database name Cook, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
264
Critical
5
Severe
51
Most recent
2021-12-29

Of the 264 recalls from Cook, Inc. we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (19%) 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.

51–75 of 264

  • HighFDA (Devices)·Z-0959-2020·2020-02-12

    Cook Inc. Recalls Bentson PTFE Wire Guides Due to Loading Error

    Cook Inc. is recalling Bentson PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2020·2020-02-12

    Cook Inc. Recalls C-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling C-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.

    Product
    Urethral Dilator Set, Global Product No. G14185
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2020·2020-02-12

    Cook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets

    Cook Inc. is recalling Bander Ureteral Diversion Open-End Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2020·2020-02-12

    Cook Inc. Recalls Roadrunner Hydrophilic PC Wire Guides Due to Loading Error

    Cook Inc. is recalling Roadrunner Hydrophilic PC Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2020·2020-02-12

    Cook Percutaneous Pigtail Nephrostomy Set Recalled for Wire Guide Loading Error

    Cook Inc. is recalling Percutaneous Pigtail Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2020·2020-02-12

    Cook Inc. Recalls Wire Guide Due to Incorrect Loading Risk

    Cook Inc. is recalling 13,388 Wire Guide units because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Wire Guide, Guidewire, Global Product Number G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Double Pigtail Ureteral Stent Sets

    Cook Inc. is recalling Sof-Flex Double Pigtail Ureteral Stent Sets because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilation Balloon Catheters Due to Wire Guide Defect

    Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2020·2020-02-12

    Cook Inc. Recalls Universa Firm Ureteral Stents Due to Loading Error

    Cook Inc. is recalling Universa Firm Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.

    Product
    Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2020·2020-02-12

    Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

    Product
    Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2020·2020-01-22

    Cook Inc. Recalls Dawson-Mueller Drainage Catheters Due to Leakage Risk

    Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters because they were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

    Product
    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0588-2020·2019-12-18

    Cook CrossCath Support Catheter Recalled for Manufacturing Error

    Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0589-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

    Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0590-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Marker Band Fit Issues

    Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0432-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 1,125 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 95 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 585 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 1,679 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide and across the US.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2020·2019-11-27

    Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

    Cook Inc. is recalling 470 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.

    Product
    Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide