Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Approach Hydro ST Micro Wire Guide Recalled by Cook Incorporated Due to Affected device lots have labels that state the...

Date: October 8, 2024
Company: Cook Incorporated
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cook Incorporated directly.

Affected Products

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

Quantity: 5,953 US; 2,528 OUS

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cook Incorporated

Cook Incorporated has 64 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report