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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cook
- Product type
- Wire Guide (Micro Wire Guide)
- Model numbers
- UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Match lot number 15288005 to the recalled lots
- Confirm Reference Part Number CMW-14-190-6G on the device label
- 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
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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
- Hazard Level: HIGH
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Safety Guide
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