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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 2 of 194

Device	Model / Reference	Registries	Class	Status
Roadrunner UniGlide	G56177	FDA UDI	Class II	Active
Zenith Flex	G48453	FDA UDI	Class III	Unknown
Cook Spectrum Turbo-Ject	G56198	FDA UDI	Class II	Unknown
Cook	G47555	FDA UDI	Class II	Active
Cook Spectrum Turbo-Ject	G34557	FDA UDI	Class II	Active
Bush	G16737	FDA UDI	Class II	Active
Cook	G15935	FDA UDI	Class II	Active
Flexi-Tip	G15579	FDA UDI	N	Unknown
Cook	G14688	FDA UDI	Class II	Active
Amplatz	G03041	FDA UDI	Class II	Active
Nester	G47371	FDA UDI	Class II	Active
Universa	G23376	FDA UDI	Class II	Active
Turbo-Flo HD	G35088	FDA UDI	Class II	Active
Echotip	G16288	FDA UDI	Class I	Active
Cook	G51536	FDA UDI	Class II	Active
Royal Flush	G04848	FDA UDI	Class II	Active
Cook	G17472	FDA UDI	Class II	Active
Cook Spectrum	G48113	FDA UDI	Class II	Active
Cook	G46242	FDA UDI	Class II	Active
Soft-Trans	G26640	FDA UDI	Class II	Unknown
Cook	G09266	FDA UDI	Class I	Active
Beacon Tip Torcon NB	G08642	FDA UDI	Class II	Active
Cook	G23733	FDA UDI	Class II	Active
Cook	G23288	FDA UDI	Class II	Active
Performer Balkin	G07339	FDA UDI	Class II	Active
Peel-Away	G11569	FDA UDI	Class II	Unknown
Cook Spectrum	G44802	FDA UDI	Class II	Active
Torcon NB	G47070	FDA UDI	Class II	Active
Cook Spectrum	G24755	FDA UDI	Class II	Active
Amplatz	G01683	FDA UDI	Class II	Active
Cook	G29406	FDA UDI	Class II	Active
Fusion	G57301	FDA UDI	Class II	Active
TriForce	G56415	FDA UDI	Class II	Active
Advance	G30825	FDA UDI	Class II	Active
Cook	G14188	FDA UDI	Class II	Active
Advance	G19006	FDA UDI	Class II	Active
Fusion Zilver	G31555	FDA UDI	Class II	Unknown
Cook	G17920	FDA UDI	Class I	Active
Universa	G53237	FDA UDI	Class II	Active
Performer	G07707	FDA UDI	Class II	Active
Zenith Renu	G36142	FDA UDI	Class III	Active
Flexor	G13338	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G11378	FDA UDI	Class II	Active
Torcon NB	G47106	FDA UDI	Class II	Active
Cook	G14941	FDA UDI	Class II	Active
Cook	G50148	FDA UDI	Class II	Active
Cook	G30368	FDA UDI	Class II	Active
Ultrathane	G17132	FDA UDI	Class II	Active
Cook	G02925	FDA UDI	Class II	Active
Nester	G31458	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.