HIGH

Cook Medical CTO-6 Micro Wire Guide Recalled Worldwide Over Expired Shelf Life Labels (2026)

Cook Medical recalled 15 CTO-6 Micro Wire Guides sold worldwide after labeling errors extended expiration dates beyond true shelf life. The devices carry Reference Part Number CMW-14-190-6G and Order Number G50786. Healthcare providers were notified to stop use immediately until further instructions.

Quick Facts at a Glance

Recall Date
March 5, 2026
Hazard Level
HIGH
Brand
Cook
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

Hazard Information

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

The CTO-6 Micro Wire Guide is a medical device used in complex coronary procedures. It helps access difficult vessels and support interventional techniques.

Why This Is Dangerous

Expiration date labeling beyond shelf life could affect device reliability or performance, posing patient safety risks.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Immediate action required. Hospitals and clinics must verify inventory and follow recall instructions to prevent potential unsafe use.

Practical Guidance

How to identify if yours is affected

  1. Match lot number 15288005 to the recalled lots
  2. Confirm Reference Part Number CMW-14-190-6G on the device label
  3. Review recall notice on FDA site

Where to find product info

FDA recall page Z-1775-2026 and Cook Medical recall communications

What timeline to expect

Remedy timelines will be provided by Cook; expect several weeks for replacement or guidance

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File a report with the manufacturer
  • Contact FDA if manufacturer is nonresponsive

How to prevent similar issues

  • Verify shelf life labels on all medical devices before use
  • Adhere to device expiration guidelines from manufacturers
  • Maintain inventory controls to isolate recalled lots

Documentation advice

Keep recall notices, lot numbers, dates, and correspondence with Cook for record-keeping

Product Details

Product: Approach CTO-6 Micro Wire Guide. Reference Part Number CMW-14-190-6G. Order Number G50786. Quantity: 15 units. Distribution: Worldwide. Recall date: 2026-03-05. Manufacturer: Cook Incorporated.

Reported Incidents

No injuries or incidents have been reported in the available information.

Key Facts

  • 15 units recalled
  • RecallDate: 2026-03-05
  • Status: ACTIVE
  • Hazard Level: HIGH
  • Model/UDI: UDI 01)00827002507869(17)270708(10)15288005; Lot Number 15288005
  • Distribution: Worldwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLYPREGNANT
Injury Types
ELECTRICALOTHER

Product Details

Brand
Model Numbers
UDI (01)00827002507869(17)270708(10)15288005
Lot Number 15288005
Report Date
April 15, 2026
Recall Status
ACTIVE

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