Cook Incorporated

13 FDA enforcement actions

13 Total Recalls

1 Class I

12 Class II

0 Class III

Firm Details

Product Types: device
States: IN

All Recalls

Class II: Risk 11/26/2025 device

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.
Class II: Risk 11/26/2025 device

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.
Class II: Risk 11/26/2025 device

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.
Class I: Dangerous 05/15/2025 device

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Class II: Risk 04/17/2025 device

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class II: Risk 04/17/2025 device

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class II: Risk 04/17/2025 device

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Class II: Risk 10/14/2024 device

Devices from the affected device lots have labels that state the incorrect expiration dates.
Class II: Risk 10/08/2024 device

Affected device lots have labels that state the incorrect expiration dates.
Class II: Risk 10/08/2024 device

Affected device lots have labels that state the incorrect expiration dates.
Class II: Risk 09/16/2024 device

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.
Class II: Risk 05/15/2024 device

Product labels state the incorrect expiration dates that extends beyond their true expiration date
Class II: Risk 05/15/2024 device

Product labels state the incorrect expiration dates that extends beyond their true expiration date

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.