Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health 200
- 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 200
- Product type
- ENFit Salem Sump PVC Enteral Tube
- Model numbers
- 8888264911E ENFit SALEM SUMP PVC TUBE 10FR 36IN, 8888264929E ENFit SALEM SUMP PVC TUBE 12FR 48IN, 8888264945E ENFit SALEM SUMP PVC TUBE 14FR 48IN, 8888264960E ENFit Salem Sump PVC Tube 16Fr 48IN, 8888264986E ENFit SALEM SUMP PVC TUBE 18FR 48IN, 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN, 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN, 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN +4 more
- Sizes
- 10FR 36IN, 12FR 48IN, 14FR 48IN, 16FR 48IN, 18FR 48IN +2 more
- 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 tubes are enteral drainage or feeding tubes used in clinical settings. The ENFit connectors standardize compatibility with feeding systems.
Why This Is Dangerous
ARV breakage can compromise tube function and raise safety concerns during use, potentially affecting patient care.
Industry Context
Expansion of recall RES 95214 continues to address ARV components in enteral tubes.
Real-World Impact
Hospitals and clinics may need to halt use of affected tubes, potentially disrupting patient care and supply chains. Providers should follow recall instructions to minimize risk.
Practical Guidance
How to identify if yours is affected
- Review the recall notice and list of product codes
- Inspect current inventory for ENFit Salem Sump tubes and ARV variants
- Check UDI-DI details and model names against the listed codes
- Verify if any lots are in use with ARV components
Where to find product info
Recall pages and the FDA enforcement site provide the product codes, UDI-DI, and supplier instructions
What timeline to expect
Remediation typically progresses within weeks; follow supplier timelines and doctor orders
If the manufacturer is unresponsive
- Escalate to hospital procurement or patient safety officer
- File a complaint with the manufacturer and, if needed, contact FDA for guidance
How to prevent similar issues
- Source enteral tubes from authorized distributors
- Verify ARV components and ENFit connections before use
- Stay updated with recall communications and supplier notices
- Train staff on recognizing ARV-related issues
Documentation advice
Keep recall letters, document tube codes, save supplier instructions, photograph packaging and labels
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product Codes/Names include: 8888264911E ENFit Salem SUMP PVC TUBE 10FR 36IN; 8888264929E ENFit Salem SUMP PVC TUBE 12FR 48IN; 8888264945E ENFit Salem SUMP PVC TUBE 14FR 48IN; 8888264960E ENFit Salem SUMP PVC TUBE 16FR 48IN; 8888264986E ENFit Salem SUMP PVC TUBE 18FR 48IN; 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN; 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN; 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN; 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN; 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN; 8888268060E ENFit Salem SUMP PVC TUBE 6FR 24IN; 888
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- ARV breakage reported in ENFit Salem Sump tubes
- Worldwide distribution including US states and multiple countries
- 29+ product codes/models affected
- Recall began 2025-09-18; status ACTIVE
- Expansion of RES 95214 noted by firm
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.