Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health 200
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 200
- Product type
- Salem Sump Stomach Tube (Dual Lumen)
- Model numbers
- 264929, 264945, 264960, 264986, 5558264957, 5558264965, 5558264973, 5558264981 +6 more
- 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
Salem Sump dual-lumen stomach tubes are enteral feeding and decompression devices used in medical settings to manage gastric contents. They come in multiple sizes and configurations and are distributed to hospitals and clinics.
Why This Is Dangerous
The Anti-Reflux Valve is vulnerable to breakage under 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
Hospitals may need to replace affected tubes to maintain safety. The recall could affect supply chains and require provider switching to alternative enteral tubes.
Practical Guidance
How to identify if yours is affected
- 1. Locate model numbers on the device or packaging.
- 2. Compare with recalled model list.
- 3. Check UDI-DI codes if available.
Where to find product info
Look for the recall notice and UDI codes in the FDA page and Cardinal Health recall communications.
What timeline to expect
Recalls typically finalize refund or replacement steps within weeks to months, depending on provider coordination.
If the manufacturer is unresponsive
- Escalate to the hospital supply chain or medical device distributor.
- File a report with the FDA if you encounter unaddressed safety concerns.
How to prevent similar issues
- Verify device ARV integrity before use.
- Follow manufacturer and hospital guidelines for handling enteral tubes.
- Ask suppliers for ARV design details and any updated guidance.
Documentation advice
Keep the recall notice, product labels, purchase records, and communications with providers for reference.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- GLOBAL recall with all lots affected
- ARV breakage linked to excessive force
- Arbitrary ARV failures may impact patient care
- Model numbers listed above are subject to recall
- No reported injuries to date
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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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