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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 12 of 194

Device	Model / Reference	Registries	Class	Status
Formula 418	G42919	FDA UDI	Class II	Active
Dash	G57298	FDA UDI	Class II	Active
Cook	G29774	FDA UDI	U	Active
Cook Spectrum Turbo-Ject	G23710	FDA UDI	Class II	Active
Zenith Renu	G55388	FDA UDI	Class III	Active
Amplatz	G16116	FDA UDI	Class II	Active
Zenith Renu	G55406	FDA UDI	Class III	Active
Universa	G49901	FDA UDI	Class II	Active
Torcon NB	G07300	FDA UDI	Class II	Active
Cook	G05251	FDA UDI	Class I	Unknown
Flexor	G30001	FDA UDI	Class II	Active
Beacon Tip Torcon NB	G11201	FDA UDI	Class II	Active
Nester	G47364	FDA UDI	Class II	Active
Lumax	G47631	FDA UDI	Class II	Active
White Lumax	G27940	FDA UDI	Class II	Active
Advance	G26898	FDA UDI	Class II	Active
Torcon NB	G04787	FDA UDI	Class II	Active
Cook	G04876	FDA UDI	Class II	Active
Approach	G50783	FDA UDI	Class II	Active
Cook	G47308	FDA UDI	Class II	Active
Malecot	G16925	FDA UDI	Class II	Active
Fusion	G26726	FDA UDI	Class II	Unknown
Cook	G58872	FDA UDI	Class II	Active
Cook	G56891	FDA UDI	U	Active
Advance	G18924	FDA UDI	Class II	Active
Cook	G01005	FDA UDI	Class II	Active
Cook	G00004	FDA UDI	Class II	Active
Cohen	G29953	FDA UDI	Class II	Active
Universa	G49932	FDA UDI	Class II	Active
Cook	G58420	FDA UDI	Class II	Active
Formula 418	G42955	FDA UDI	Class II	Active
Instinct	G57302	FDA UDI	Class II	Active
Cook	G23261	FDA UDI	Class II	Active
Universa	G17202	FDA UDI	Class II	Active
Cook	G14173	FDA UDI	Class II	Active
Arndt	G13282	FDA UDI	Class II	Active
Cook	G03570	FDA UDI	Class II	Active
Sof-Flex	G14789	FDA UDI	Class II	Active
Approach	G50791	EUDAMEDFDA UDI	Class II	Active
Turbo-Ject	G34519	FDA UDI	Class II	Unknown
Instinct	G18343	FDA UDI	Class II	Active
Cook-Cope Loop	G14917	FDA UDI	U	Active
Amplatz	G11977	FDA UDI	U	Active
Cook	G00997	FDA UDI	Class II	Active
Formula 418	G42937	FDA UDI	Class II	Active
Cook	G00663	FDA UDI	Class II	Active
Cook	G02008	FDA UDI	Class II	Active
Cook	G00048	FDA UDI	Class II	Active
Royal Flush	G31101	FDA UDI	Class II	Active
Performer	G11316	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.