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
58
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 58 (22%) 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 264

  • SevereFDA (Devices)·Z-0596-2021·2020-12-30

    Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications

    The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0591-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0607-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0399-2021·2020-11-11

    Cook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects

    Cook Inc. is recalling 61 Fixed Core Wire Guides that may be bent or contain loose foreign matter due to being dropped during manufacturing.

    Product
    Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0105-2021·2020-10-21

    Cook Inc. Recalls Percutaneous Neonatal Pigtail Nephrostomy Sets

    Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.

    Product
    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0106-2021·2020-10-21

    Cook Inc. Recalls Pediatric Nephrostomy Stent Sets Due to Labeling Update

    Cook Inc. is recalling 380 Pediatric Nephrostomy Stent Sets because the indwell time is decreasing from 4 months to 4 weeks. The Instructions for Use are being updated to reflect this change.

    Product
    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2020·2020-09-23

    Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue

    Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2971-2020·2020-09-23

    Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error

    Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.

    Product
    Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2546-2020·2020-07-15

    Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing

    Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1940-2020·2020-05-20

    Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents

    Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.

    Product
    Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system.…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1566-2020·2020-04-01

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Spectrum Central Venous Catheter Trays because the printed expiration dates are incorrect. The devices were distributed to seven US states and Canada.

    Product
    Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1565-2020·2020-04-01

    Cook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Pericardiocentesis Sets because the printed expiration dates are incorrect. The products were distributed to seven US states and Canada.

    Product
    Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1355-2020·2020-03-04

    Cook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts

    Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts due to identified factors contributing to thrombus formation and lumen occlusion. The product is distributed only outside the United States.

    Product
    Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0976-2020·2020-02-12

    Cook Inc. Recalls Sof-Flex Ureteral Stent Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Sof-Flex Multi-Length Ureteral Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient.

    Product
    Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
    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-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-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-0967-2020·2020-02-12

    Cook Inc. Recalls Percutaneous Entry Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling 13,388 Percutaneous Entry 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 Entry Set, Nephrostomy Catheter, Global Product No. G14649
    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-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-0978-2020·2020-02-12

    Cook Inc. Recalls Universa Soft Ureteral Stents Due to Wire Guide Loading Error

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

    Product
    Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2020·2020-02-12

    Cook Inc. Recalls Percutaneous Malecot Nephrostomy Sets Due to Wire Guide Loading Error

    Cook Inc. is recalling 13,388 Percutaneous Malecot Nephrostomy Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
    Category
    Medical Device
    Distribution
    Distributed nationwide