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, PREGNANT, PETS
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
- Gastroduodenal Tube
- Model numbers
- 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm, 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm, 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm, 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm, 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm, 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm, 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm, 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm +8 more
- Sizes
- 10 Fr, 12 Fr, 14 Fr, 16 Fr, 18 Fr +11 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 gastroduodenal tubes are used for feeding and decompression in clinical settings. They come in PVC and polyurethane variants with multiple French sizes and lengths.
Why This Is Dangerous
Excessive force can cause ARV breakage, potentially compromising tube function and safety for patients.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate disposal or replacement is necessary to avoid potential device failure during patient care.
Practical Guidance
How to identify if yours is affected
- Review product codes and UDI-DI references listed in the recall.
- Match size, length, and material (PVC or polyurethane) to the listed models.
- Check for ARV components and their condition.
Where to find product info
Recall notice and FDA enforcement page linked in the notice.
What timeline to expect
Replacement or refund timelines are not specified; contact the manufacturer for progression details.
If the manufacturer is unresponsive
- Document all attempts to contact Cardinal Health 200, LLC.
- Escalate with hospital risk management or nurse educator.
- Consider filing MedWatch if injuries occur.
How to prevent similar issues
- Verify ARV integrity before use.
- Use only recommended handling procedures from the manufacturer.
- Be aware of valve components in gastroduodenal tubes when selecting devices.
Documentation advice
Keep recall notification, model numbers, serial numbers, and correspondence with supplier; photograph ARV if needed.
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 multiple Salem Sump PVC and polyurethane gastroduodenal tubes, sizes 10 Fr to 20 Fr. Some variants list different lengths, including 90 cm, 114 cm, and 108 cm. UDI-DI references are listed for several models. Distribution is worldwide, including all US states and numerous international markets.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- HIGH hazard level
- Class II recall
- Global distribution including US and many countries
- ARV breakage due to excessive force
- Multiple product codes and lengths
- No injuries reported in available data
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.