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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 19 of 194

Device	Model / Reference	Registries	Class	Status
Roadrunner	G09609	FDA UDI	Class II	Active
Formula 418	G56618	FDA UDI	Class III	Active
Kwart	G15015	FDA UDI	Class II	Active
van Andel	G01383	FDA UDI	Class II	Active
Cook	G01294	FDA UDI	Class II	Active
Captura	G32784	FDA UDI	Class II	Active
Cook	G00808	FDA UDI	Class II	Active
Cook	G58817	FDA UDI	Class II	Active
TriForce	G56416	FDA UDI	Class II	Active
Torcon NB	G47027	FDA UDI	Class II	Active
Cook	G00525	FDA UDI	Class II	Active
Cook TPN	G07902	FDA UDI	Class II	Unknown
Cook	G01042	FDA UDI	Class II	Active
Torcon NB	G31070	FDA UDI	Class II	Active
Cook	G14230	FDA UDI	Class II	Active
Echotip	G16284	FDA UDI	Class I	Active
Royal Flush	G05770	FDA UDI	Class II	Active
Cook	G00881	FDA UDI	Class II	Active
Universa	G53719	FDA UDI	Class II	Active
Tornado	G47544	FDA UDI	Class II	Active
Nester	G47359	FDA UDI	Class II	Active
Soft-Trans	G49408	FDA UDI	Class II	Unknown
Flexor	G27935	FDA UDI	Class II	Active
Retracta	G34192	FDA UDI	Class II	Active
Advance	G52328	FDA UDI	Class II	Active
Advance	G30766	FDA UDI	Class II	Active
Roadrunner UniGlide	G30493	FDA UDI	Class II	Active
Cook	G08080	FDA UDI	Class I	Active
Flexor	G08681	FDA UDI	Class II	Active
Zenith	G12481	FDA UDI	Class III	Active
Universa	G53694	FDA UDI	Class II	Active
Universa	G23356	FDA UDI	Class II	Active
Greene	G16228	FDA UDI	Class II	Unknown
Cook	G14095	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G11203	FDA UDI	Class II	Active
Slip-Cath Beacon Tip	G12005	FDA UDI	Class II	Active
Cook	G01402	FDA UDI	Class II	Active
Universa	G49959	FDA UDI	Class II	Active
Wayne	G56532	FDA UDI	Class II	Active
Captura	G56087	FDA UDI	Class II	Active
Amplatz	G03750	FDA UDI	Class II	Active
Universa	G23352	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G11642	FDA UDI	Class II	Active
Cook	G06118	FDA UDI	Class II	Active
Cook	G58985	FDA UDI	Class II	Active
Kopans	G01193	FDA UDI	Class I	Active
Slip-Cath Beacon Tip	G31337	FDA UDI	Class II	Active
Advance	G26896	FDA UDI	Class II	Active
Cook	G17897	FDA UDI	Class I	Active
Cook	G05502	FDA UDI	Class I	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.