Cook Incorporated: Device Recall

Recall #Z-0347-2025 · 10/08/2024

Class II: Risk

Recall Details

Recall Number: Z-0347-2025
Classification: Class II
Product Type: Device
Recalling Firm: Cook Incorporated
Status: Ongoing
Date Initiated: 10/08/2024
Location: Bloomington, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,953 US; 2,528 OUS

Reason for Recall

Affected device lots have labels that state the incorrect expiration dates.

Product Description

Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by Cook Incorporated

Class II: Risk 11/26/2025

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

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

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

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

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

View all recalls by Cook Incorporated →

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.