Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
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
- Introducer Sheaths
- Model numbers
- Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL0-HC: Order Number G49101, UDI (01)00827002491014(17)280708(10)16683401, Lot Number 16683401, Reference Part Number (RPN)KCFW-9.0-18/38-45-RB-ANL1-HC: Order Number G49102, UDI (01)00827002491021(17)280709(10)16685978, Lot Number 16685978, UDI (01)00827002491021(17)280804(10)NS16724225, Lot Number NS16724225 +8 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
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: Letter
About This Product
Flexor Check-Flo introducers and guiding sheaths are designed for use in medical procedures to facilitate the introduction of other devices. They are commonly used in minimally invasive surgeries and vascular access procedures.
Why This Is Dangerous
The recall is due to manufacturing errors where devices may have been cut incorrectly or not trimmed properly. This can lead to problems during medical procedures, potentially jeopardizing patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the affected devices immediately to avoid possible complications during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the reference part number against the recall list.
- Verify the lot number on the product packaging.
- Contact your healthcare provider for assistance.
Where to find product info
Reference part numbers and lot numbers can typically be found on the product's packaging or label.
What timeline to expect
Expect a 4-6 week timeline for receiving refunds or replacements.
If the manufacturer is unresponsive
- Document all communication attempts with Cook Medical.
- Report the issue to the FDA if you do not receive a response.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Ensure devices are from reputable manufacturers.
- Review the product specifications and recall notices regularly.
Documentation advice
Keep records of your communications with Cook Medical, including dates and content of discussions.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects Flexor Check-Flo introducers and sets with various reference part numbers including KCFW-9.0-18/38-45-RB-ANL0-HC and KCFW-10.0-35-45-RB-HFANL0-HC. These devices were distributed worldwide and sold through multiple retailers.
Key Facts
- Manufactured out of specification
- Stop using immediately
- Contact Cook Medical for instructions
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.