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, PETS
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
- Micro Wire Guide
- Model numbers
- Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X, UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X, Reference Part Number CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547.
- 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
Cook Medical Approach CTO-12 Micro Wire Guide is a device used in complex vascular procedures to steer catheters.
Why This Is Dangerous
Incorrect expiration labeling could imply compromised shelf life, potentially affecting sterility or performance.
Industry Context
This recall is not clearly stated as part of a broader industry pattern.
Real-World Impact
No injuries reported yet; potential impact includes need for verification and possible device replacement in clinical settings.
Practical Guidance
How to identify if yours is affected
- Identify Reference Part Numbers CMW-14-190-12G and CMW-14-300-12G
- Match associated order numbers G50787 and G50791
- Verify expiration dates against true shelf life on label
Where to find product info
FDA recall page linked in recall notice and Cook Medical customer service
What timeline to expect
Replacement/refund process to follow Cook recall instructions, typically weeks to months
If the manufacturer is unresponsive
- Escalate to FDA recall office
- File consumer complaint with FDA
- Consult healthcare provider for clinical guidance
How to prevent similar issues
- Verify shelf life labeling during procurement
- Maintain traceability by lot and order numbers
- Follow supplier recalls promptly
- Document all communications and actions
Documentation advice
Keep recall notice, batch/lot numbers, purchase records, and any correspondence with Cook or healthcare providers
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Product Details
Product: Cook Medical Approach CTO-12 Micro Wire Guide. Reference Part Numbers: CMW-14-190-12G (Order Number G50787) and CMW-14-300-12G (Order Number G50791). Distribution: Worldwide. Recall date: 2026-03-05. Quantity: 49 units. Classification: Class II.
Reported Incidents
No specific injuries or incidents are described in the provided information.
Key Facts
- Two reference part numbers: CMW-14-190-12G and CMW-14-300-12G
- Order numbers G50787 and G50791
- Expiration dates exceed true shelf life
- Class II recall
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Safety Guide
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