Cook Incorporated
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000003180 FEI 1825146
- Devices
- 9,912
- Registrations
- EUDAMEDFDA
- FDA recalls
- 10585 ongoing
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Cook Medical Europe LimitedIE
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.
Catalogue
Search and filter all 9,912 devicesShowing 1-50 of 9,912
Company details
- EUDAMED SRN
- US-MF-000003180
- SRN (system / procedure pack)
- US-PR-000019790
- FDA FEI number
- 1825146
- DUNS number
- 079720472
- EUDAMED status
- Active
- EUDAMED registered name
- Cook Incorporated
- EUDAMED abbreviated name
- Cook Inc.
- Registered address
- 750 Daniels way, 47404, Bloomington, United States
- Website
- www.cookmedical.com/
- Phone
- +1 812 339 2235
- PRRC contact
- Matt Graf
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 25 Jun 2029
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 045257 0081 Active
Quality management system EU MDR
- Issued
- 5 Oct 2026
- Expires
- 25 Jun 2029
- Reason
- Change approved
FDA recalls
FDA recall records list 86 recalls initiated by COOK INCORPORATED, the earliest on 2022-05-05 and the most recent on 2026-09-16. By recorded status: 85 ongoing and 1 with another status. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 41
- 2023 2
- 2024 14
- 2025 7
- 2026 22
2026
- 16 Sep 2026 Z-0163-2027 Class II Ongoing The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
- 2 Apr 2026 Z-1934-2026 Class I Ongoing 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.
Full distribution text
- 2 Apr 2026 Z-1935-2026 Class I Ongoing 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.
Full distribution text
- 2 Apr 2026 Z-1936-2026 Class I Ongoing 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.
Full distribution text
- 5 Mar 2026 Z-1775-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1776-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1777-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1778-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1779-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1780-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Show the 25 most recent of 105 recalls
2026
- 5 Mar 2026 Z-1781-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1782-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1783-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1784-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1785-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1786-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1787-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1788-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1789-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1790-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1791-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 5 Mar 2026 Z-1792-2026 Class II Ongoing Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2025
- 26 Nov 2025 Z-0993-2026 Class II Ongoing 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.
- 26 Nov 2025 Z-0994-2026 Class II Ongoing 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.
- 26 Nov 2025 Z-0995-2026 Class II Ongoing 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.
Frequently asked questions
How many devices does COOK INCORPORATED have in the registry?
The registry currently lists 9912 devices for COOK INCORPORATED. Devices recorded under merged duplicate company entries are counted once.
Which registries list COOK INCORPORATED's devices?
Among its 50 most recently registered devices, COOK INCORPORATED has devices listed in EUDAMED (27 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do COOK INCORPORATED's devices fall under?
Among its 50 most recently registered devices, the classes recorded for COOK INCORPORATED's devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for COOK INCORPORATED?
FDA recall records list 105 recalls initiated by COOK INCORPORATED, the most recent initiated on 16 Sep 2026. 85 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for COOK INCORPORATED?
EUDAMED lists 1 certificate for COOK INCORPORATED (quality management system) under MDR. The most recent was issued on 5 Oct 2026.
What are the newest devices from COOK INCORPORATED in the registry?
The most recently registered devices listed for COOK INCORPORATED include Check-Flo®, Amplatz, OpTUS Ultra Pleural G60661 and OpTUS Ultra Pleural G60662.