Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- 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
- Cardinal Health
- Product type
- Anti-Reflux Valve
- Model numbers
- 266197, 10884527022762, 8888266197, 10192253012866
- Sold at
- Unknown
- 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
Salem Sump PVC Tubes with Anti-Reflux Valve are used in clinical settings to manage enteral or related fluid pathways.
Why This Is Dangerous
The ARV can break when subjected to excessive force, potentially compromising device function and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians and facilities may need to replace affected ARV components, leading to workflow disruptions and potential treatment delays.
Practical Guidance
How to identify if yours is affected
- Look for product code 266197 on the device packaging or labeling.
- Check UDI-DI: 10884527022762 on labeling.
- Verify that all lots are within scope of this recall.
Where to find product info
Refer to FDA enforcement page and Cardinal Health recall notices for instructions.
What timeline to expect
Remediation steps will be provided by Cardinal Health; typical processing timelines vary by facility, but expect several weeks.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement contacts.
- File a formal inquiry with Cardinal Health if you do not receive clear remediation steps within 1-2 weeks.
How to prevent similar issues
- Verify ARV components are used per manufacturer guidelines.
- Train staff on recognizing ARV breakage indicators.
- Maintain a tracked inventory to isolate and quarantine recalled devices.
Documentation advice
Document all identified devices, associated lot numbers, and communications with Cardinal Health 200.
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Product Details
Product Code/Product Name: 266197 Salem Sump Anti-Reflux Valve (CE Marked) UDI-DI: 10884527022762 Other identifiers: 8888266197, 10192253012866 Quantity: All lots Distribution: Worldwide, including US states listed and numerous countries Sold through: Healthcare channels (not consumer retailers)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: All lots
- Arv: Anti-Reflux Valve breakage due to excessive force
- Distribution: Worldwide (US and international)
- Hazard level: HIGH
- Status: ACTIVE recall
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Safety Guide
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