Cook Biotech, Inc.
United StatesFDA applicant, unverified FDA FEI 3002340648
- Devices
- 31
- Registrations
- FDA
- FDA recalls
- 1615 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Cook Biotech, Inc. makes
Cook Biotech, Inc. manufactures medical devices such as hybrid grafts, fistula plugs (including recto-vaginal and facial types), staple line reinforcements, hernia repair grafts, wound matrices, urological grafts, and surgical meshes for plastic and reconstructive surgery.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 31 devicesCompany details
- FDA FEI number
- 3002340648
- Address
- 1425 INNOVATION PLACE, West Lafayette, IN, 47906
FDA recalls
FDA recall records list 16 recalls initiated by Cook Biotech, Inc., the earliest on 2002-12-13 and the most recent on 2024-11-22. By recorded status: 15 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. 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 0
- 2023 0
- 2024 15
- 2025 0
- 2026 0
2024
- 22 Nov 2024 Z-0832-2025 Class II Ongoing Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- 22 Nov 2024 Z-0833-2025 Class II Ongoing Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- 22 Nov 2024 Z-0834-2025 Class II Ongoing Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- 7 Aug 2024 Z-3250-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3251-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3252-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3253-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3254-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3255-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3256-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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Show all 16 recalls
2024
- 7 Aug 2024 Z-3257-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3258-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3259-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3260-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3261-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
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- 7 Aug 2024 Z-3257-2024 Class II Ongoing Products expire prior to the expiration date printed on the product labeling
2002
- 13 Dec 2002 Z-0577-03 Unclassified (pre-2012) Terminated Adverse events- suspected pseudoaneurysm
Frequently asked questions
How many devices does Cook Biotech, Inc. have in the registry?
The registry currently lists 31 devices for Cook Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cook Biotech, Inc.'s devices?
Among its 31 most recently registered devices, Cook Biotech, Inc. has devices listed in FDA 510(k) (31 devices).
What risk classes do Cook Biotech, Inc.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Cook Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cook Biotech, Inc.?
FDA recall records list 16 recalls initiated by Cook Biotech, Inc., the most recent initiated on 22 Nov 2024. 15 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 are the newest devices from Cook Biotech, Inc. in the registry?
The most recently registered devices listed for Cook Biotech, Inc. include HYBRID GRAFT, SIS FISTULA PLUG, SURGISIS STAPLE LINE REINFORCEMENT II and SURGISIS RVP RECTO-VAGINAL FISTULA PLUG.