Cook Biotech, Inc.

15 FDA enforcement actions

15 Total Recalls

0 Class I

15 Class II

0 Class III

Firm Details

Product Types: device
States: IN

All Recalls

Class II: Risk 11/22/2024 device

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II: Risk 11/22/2024 device

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II: Risk 11/22/2024 device

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling
Class II: Risk 08/07/2024 device

Products expire prior to the expiration date printed on the product labeling

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.