Cook Medical Incorporated

Country not established

Devices: 2
FDA recalls: 533 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Cook Medical Incorporated makes

Cook Medical Incorporated manufactures endovascular devices, including balloon-expandable renal stent systems for treating renal artery stenosis and thoracic endovascular grafts for aortic aneurysm repair. These products are designed for minimally invasive vascular interventions, providing structural support or occlusion within blood vessels.

The company’s portfolio is regulated under Class III medical devices in the US, requiring Premarket Approval (PMA) through the FDA. These devices are listed under the FDA’s PMA registry, reflecting their high-risk classification requiring rigorous clinical validation before market authorisation. The company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

Formula Ballool-Expandable Renal Stent System Ref P100028

Active Regimes: PMA Registry: PMA Class:III
Zenith Alpha™ Thoracic Endovascular Graft Ref P140016 Open recall

Active Regimes: PMA Registry: PMA Class:III

FDA recalls53

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 53 recalls initiated by Cook Medical Incorporated, the earliest on 2014-09-26 and the most recent on 2025-09-18. By recorded status: 3 ongoing and 50 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 1
2018 39
2019 6
2020 0
2021 0
2022 2
2023 0
2024 2
2025 1
2026 0

2 initiated before 2017

Showing the 10 most recent of 53 recalls.

2025
- 18 Sep 2025 Z-0043-2026 Class I Ongoing Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization. Distribution: Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV…
  Full distribution text
  Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV International distribution to Switzerland, Germany, Italy, Poland, and Sweden
  Submission number: P140016
2024
- 1 Apr 2024 Z-1832-2024 Class II Ongoing Devices may contain elevated levels of bacterial endotoxin. Distribution: International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom. Submission number: K092359
- 1 Apr 2024 Z-1833-2024 Class II Ongoing Devices may contain elevated levels of bacterial endotoxin. Distribution: International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom. Submission number: K210476
2022
- 14 Feb 2022 Z-0875-2022 Class III Terminated IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events Distribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam Submission number: K211874
- 14 Feb 2022 Z-0876-2022 Class III Terminated IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events Distribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam Submission number: K211875
2019
- 25 Feb 2019 Z-1021-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K172557
- 25 Feb 2019 Z-1022-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K172557
- 25 Feb 2019 Z-1023-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K172557
- 25 Feb 2019 Z-1024-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K171712
- 25 Feb 2019 Z-1025-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K171712

Show the 25 most recent of 53 recalls

2019
- 25 Feb 2019 Z-1026-2019 Class III Terminated Updates to the Instructions for Use. Distribution: The products were distributed US Nationwide Distribution Submission number: K171712
2018
- 25 Sep 2018 Z-0314-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0315-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0316-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0317-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0318-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0319-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0320-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0321-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0322-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0323-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K050698
- 25 Sep 2018 Z-0324-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K043481
- 25 Sep 2018 Z-0325-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K043481
- 25 Sep 2018 Z-0326-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K043481
- 25 Sep 2018 Z-0327-2019 Class II Terminated The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. Distribution: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…
  Full distribution text
  US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
  Submission number: K043481

Frequently asked questions

How many devices does Cook Medical Incorporated have in the registry?

The registry currently lists 2 devices for Cook Medical Incorporated. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cook Medical Incorporated's devices?

Among its 2 most recently registered devices, Cook Medical Incorporated has devices listed in FDA PMA (2 devices).

What risk classes do Cook Medical Incorporated's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Cook Medical Incorporated's devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Cook Medical Incorporated?

FDA recall records list 53 recalls initiated by Cook Medical Incorporated, the most recent initiated on 18 Sep 2025. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Cook Medical Incorporated in the registry?

The most recently registered devices listed for Cook Medical Incorporated include FORMULA BALLOOL-EXPANDABLE RENAL STENT SYSTEM and Zenith Alpha™ Thoracic Endovascular Graft.

Generated automatically from registry data and not verified by a human reviewer.