Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Cardinal Health
- Product type
- Salem Sump Dual-Lumen Stomach Tube with Anti-Reflux Valve
- Model numbers
- 266122 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve 14 Fr, 266130 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve 16 Fr, 266148 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve 18 Fr, 8888266106 Salem Sump Dual Lumen Stomach Tube Anti-Reflux Valve 10 Fr 36", 266130CN Salem Sump Tube 16FR with CONFIRM NOW Nonsterile, 266148CN Salem Sump Tube 8 FR with CONFIRM NOW Nonsterile
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
A Salem Sump stomach tube is a dual-lumen gastric decompression tube used in hospitals. The Anti-Reflux Valve is designed to prevent backflow. These devices are distributed worldwide through healthcare supply channels.
Why This Is Dangerous
The ARV can break when excessive force is applied. Breakage may compromise valve function and could prompt immediate clinical intervention.
Industry Context
This recall is an expansion of RES 95214 and is not presented as part of a broader industry-wide pattern in the notice.
Real-World Impact
Hospitals may need to identify affected lots and switch to alternative devices. No injuries were reported, but ARV failure could disrupt patient care and require device replacement.
Practical Guidance
How to identify if yours is affected
- Review the recall list for product codes 266122, 266130, 266148, 8888266106, 266130CN, 266148CN.
- Examine packaging and labeling for the product name and code.
Where to find product info
Official recall notices are hosted on FDA enforcement pages and the Cardinal Health recall site.
What timeline to expect
4-8 weeks for replacement or refund processes is commonly observed in recalls, but exact timelines are not specified.
If the manufacturer is unresponsive
- Document all communications with Cardinal Health and your healthcare provider.
- Escalate to hospital risk management if the manufacturer is unresponsive.
- File a complaint with FDA recall programs if needed.
How to prevent similar issues
- Verify device codes before use in care settings.
- Provide staff training on ARV-equipped tubes and safe handling to prevent breakage.
- Verify replacement devices meet current safety standards before use.
Documentation advice
Keep recall notices, packaging, labels, and all communications. Photograph affected devices and track return or replacement actions.
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Product Details
Product Codes/Product Names: 266122 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm); 266130 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm); 266148 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch; 8888266106 Salem Sump Dual Lumen Stomach Tube, Anti-Reflux Valve 10 Fr/Ch (3.3 mm), 36"; 266130CN Salem Sump Tube 16FR with CONFIRM NOW, Nonsterile; 266148CN Salem Sump Tube 8 FR with CONFIRM NOW, Nonsterile. Distribution: Worldwide, including all US states and many countries.
Reported Incidents
ARV breakage complaints have been reported. No injuries or deaths are documented in the recall notice.
Key Facts
- ARV breakage complaints
- All lots affected
- Multiple product codes and CN variants
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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