Is this your brand? Sign in to claim ownership.

COOK INCORPORATED

United States·US-MF-000003180

Last updated September 17, 2026

What COOK INCORPORATED makes

Cook Incorporated manufactures single-use and reusable vascular and endoscopic access devices, including angiographic catheters, vascular guidewires, and dilators for tissue and vessel preparation. Their portfolio also covers embolization coils for non-neurovascular procedures, ureteral stents, and short-term central venous catheterization kits. Endoscopic-access dilators and catheter introduction sets are designed for nonimplantable use in peripheral and central vascular applications.

The company’s devices are classified under FDA categories including Class I, II, IIa, IIb, and III, with some listed under the Unique Device Identifier (UDI) system. Products are registered in the EU’s EUDAMED database and the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 750 Daniels Way, Bloomington, United States
Website: cookmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-812-339-2235
PRRC Contact: —
EUDAMED SRN: US-MF-000003180
FDA FEI Number: 1825146
DUNS Number: 079720472

Catalogue (9678)

Page 22 of 194

Device	Model / Reference	Registries	Class	Status
Captura	G56724	FDA UDI	Class II	Active
Cook	G06262	FDA UDI	Class II	Active
Cook	G14508	FDA UDI	U	Active
Torcon NB	G58422	FDA UDI	Class II	Active
Sof-Flex	G17793	FDA UDI	Class II	Unknown
Nester	G47353	FDA UDI	Class II	Active
Entuit	G47287	FDA UDI	Class II	Active
Torcon NB	G47098	FDA UDI	Class II	Active
Cook	G13355	FDA UDI	U	Active
Cook	G58841	FDA UDI	Class II	Active
Soft-Trans	G29634	FDA UDI	Class II	Unknown
Approach	G52938	FDA UDI	Class II	Active
Cook	G09765	FDA UDI	U	Active
Torcon NB	G47195	FDA UDI	Class II	Active
Amplatz	G17970	FDA UDI	Class II	Active
Flexor	G48193	FDA UDI	Class II	Active
Universa	G32725	FDA UDI	Class II	Active
Sof-Flex	G15946	FDA UDI	Class II	Active
Torcon NB	G05878	FDA UDI	Class II	Active
Dash	G57300	FDA UDI	Class II	Active
Vital-Port	G26468	FDA UDI	Class II	Active
Roadrunner	G06866	FDA UDI	Class II	Active
Roadrunner UniGlide	G56155	FDA UDI	Class II	Active
Nester	G47334	FDA UDI	Class II	Active
Soft-Pass	G17931	FDA UDI	Class II	Active
Torcon NB	G47029	FDA UDI	Class II	Active
Micropuncture	G48009	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G08805	FDA UDI	Class II	Active
Performer	G09380	FDA UDI	Class II	Active
Cook	G03994	FDA UDI	Class II	Active
Micropuncture	G47940	FDA UDI	Class II	Active
Cook	G14935	FDA UDI	Class II	Active
Torcon NB	G47206	FDA UDI	Class II	Active
Performer	G07913	FDA UDI	Class II	Active
Marcon-Haber	G22391	FDA UDI	Class II	Unknown
Turbo-Flo	G12801	FDA UDI	Class II	Unknown
Cook	G00595	FDA UDI	Class II	Active
Cook	G08064	FDA UDI	Class I	Active
Newton	G02856	FDA UDI	Class II	Active
Sof-Flex	G14830	FDA UDI	Class II	Unknown
Franseen	G04762	FDA UDI	Class I	Active
Zenith Spiral-Z	G55247	FDA UDI	Class III	Active
Flexi-Tip	G17083	FDA UDI	Class II	Active
Cook	G27399	FDA UDI	Class II	Unknown
Tornado	G47517	FDA UDI	Class II	Active
Cook	G29381	FDA UDI	Class II	Active
Amplatz	G18007	FDA UDI	Class II	Active
Cook Spectrum	G13196	FDA UDI	Class II	Active
Peel-Away	G04642	FDA UDI	Class II	Unknown
Stamey	G14871	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Cook Medical Europe Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (85)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cook Incorporated has 85 recall records initiated between May 5, 2022, and April 2, 2026. The records reflect a mix of completed, open, and classified statuses. Recalled products primarily involve packaging and labeling issues, such as insufficient seal strength, incorrect expiration dates, and improper labeling of shelf life. Manufacturing deviations, including incorrect sizing of components like embolization coils and introducer sheaths, as well as improper trimming and inspection of devices, are also noted among the reasons.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 2, 2026	Z-1936-2026	—	open, classified	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Apr 2, 2026	Z-1934-2026	—	open, classified	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Apr 2, 2026	Z-1935-2026	—	open, classified	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Mar 5, 2026	Z-1785-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1787-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1781-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1792-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1777-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1783-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1788-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1784-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1775-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1779-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1790-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1780-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1776-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1789-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1778-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1786-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1791-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Mar 5, 2026	Z-1782-2026	—	open, classified	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Nov 26, 2025	Z-0995-2026	—	open, classified	Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Nov 26, 2025	Z-0993-2026	—	open, classified	Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Nov 26, 2025	Z-0994-2026	—	open, classified	Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
May 15, 2025	Z-1902-2025	—	open, classified	Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Apr 17, 2025	Z-1786-2025	—	open, classified	Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Apr 17, 2025	Z-1762-2025	—	open, classified	Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Apr 17, 2025	Z-1787-2025	—	open, classified	Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Oct 14, 2024	Z-0499-2025	—	open, classified	Devices from the affected device lots have labels that state the incorrect expiration dates.
Oct 8, 2024	Z-0347-2025	—	open, classified	Affected device lots have labels that state the incorrect expiration dates.
Oct 8, 2024	Z-0346-2025	—	open, classified	Affected device lots have labels that state the incorrect expiration dates.
Sep 16, 2024	Z-0045-2025	—	open, classified	Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
May 15, 2024	Z-2222-2024	—	open, classified	Product labels state the incorrect expiration dates that extends beyond their true expiration date
May 15, 2024	Z-2223-2024	—	open, classified	Product labels state the incorrect expiration dates that extends beyond their true expiration date
Mar 1, 2024	Z-1532-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1528-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1525-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1531-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1530-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1529-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1526-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Mar 1, 2024	Z-1527-2024	—	open, classified	Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Apr 7, 2023	Z-1428-2023	—	open, classified	There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Apr 7, 2023	Z-1427-2023	—	open, classified	There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Aug 16, 2022	Z-1847-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1831-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1834-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1838-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1836-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1829-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1841-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1825-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1844-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1845-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1824-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1843-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1842-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1835-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1826-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1839-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1828-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1837-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1827-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1832-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1840-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1830-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1846-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Aug 16, 2022	Z-1833-2022	—	open, classified	Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Jul 19, 2022	Z-1718-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1706-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1712-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1715-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1716-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1717-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1714-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1713-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1709-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1708-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1710-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1711-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Jul 19, 2022	Z-1707-2022	—	open, classified	Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
May 25, 2022	Z-1362-2022	—	completed	The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
May 5, 2022	Z-1240-2022	—	open, classified	The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
May 5, 2022	Z-1242-2022	—	open, classified	The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
May 5, 2022	Z-1241-2022	—	open, classified	The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.