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COOK INCORPORATED

United States·US-MF-000003180

Last updated September 17, 2026

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 7 of 194

Device	Model / Reference	Registries	Class	Status
Peel-Away	G06562	FDA UDI	Class II	Active
Torcon NB	G13739	FDA UDI	Class II	Active
Onik-Cohen	G16176	FDA UDI	Class II	Unknown
Torcon NB	G11948	FDA UDI	Class II	Active
Flexor	G08246	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G11199	FDA UDI	Class II	Active
Torcon NB	G10748	FDA UDI	Class II	Active
Advance	G50252	FDA UDI	Class II	Active
Flexor	G49100	FDA UDI	Class II	Active
Flexor	G35606	FDA UDI	Class II	Active
Cook TPN	G12746	FDA UDI	Class II	Active
Cook	G02662	FDA UDI	Class II	Active
Torcon NB	G46988	FDA UDI	Class II	Active
Universa	G49886	FDA UDI	Class II	Active
Cook	G10292	FDA UDI	Class II	Active
Cook	G04144	FDA UDI	Class I	Active
Rosen	G01382	FDA UDI	Class II	Unknown
Amplatz	G18001	FDA UDI	Class II	Active
Cook	G09201	FDA UDI	Class II	Active
Torcon NB	G47000	FDA UDI	Class II	Active
Cope	G06898	FDA UDI	U	Unknown
Cook	G00274	FDA UDI	Class II	Active
Cook	G00452	FDA UDI	Class II	Active
Franseen	G01432	FDA UDI	Class I	Active
MReye	G47937	FDA UDI	Class II	Active
Cook	G09766	FDA UDI	U	Active
Amplatz	G17984	FDA UDI	Class II	Active
Cook	G29745	FDA UDI	Class II	Active
Torcon NB	G08985	FDA UDI	Class II	Active
Cook	G01304	FDA UDI	Class II	Active
Zenith Flex	G48412	FDA UDI	Class III	Active
Goldberg	G15030	FDA UDI	Class II	Active
Check-Flo	G50589	FDA UDI	Class II	Active
Cook	G01143	FDA UDI	Class II	Active
Tornado	G09952	FDA UDI	Class II	Active
Flexor	G49046	FDA UDI	Class II	Active
MReye	G19952	FDA UDI	Class II	Active
Hilal	G47508	FDA UDI	Class II	Unknown
Formula 418	G42924	FDA UDI	Class II	Active
Cook Spectrum	G51586	FDA UDI	Class II	Active
Gianturco-Rosch Cook-Z	G08556	FDA UDI	Class II	Active
Zenith Renu	G36137	FDA UDI	Class III	Active
Cook	G05848	FDA UDI	Class I	Active
Torcon NB	G47174	FDA UDI	Class II	Active
Zilver Flex 35	G50176	FDA UDI	Class II	Active
Advance	G30752	FDA UDI	Class II	Active
Universa	G49991	FDA UDI	Class II	Active
Hilal	G07156	FDA UDI	Class II	Active
Fusion	G50975	FDA UDI	Class II	Unknown
Advance	G30875	FDA UDI	Class II	Active

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.

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.