Cook Incorporated: Device Recall

Recall Details

Recall Number

Z-0346-2025

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

2,005 US; 1,145 OUS

Reason for Recall

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

Product Description

Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G

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 →