Quick Facts at a Glance
- Recall Date
- February 13, 2026
- Hazard Level
- HIGH
- Brand
- Merit Medical Systems
- 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
- Merit Medical Systems
- Product type
- 16F dual-valved splittable sheath introducer
- Model numbers
- REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562, H787103028025/A:00884450794531I3309371, H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 13, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions
About This Product
The DuraMax Chronic Hemodialysis Catheter is a long-term vascular access device used in dialysis. It includes a 16F sheath introducer that may be splittable for catheter placement.
Why This Is Dangerous
If the sheath does not split as designed, it can cause hemorrhage, leave foreign material in the patient, or delay a dialysis procedure.
Industry Context
This recall is not presented as part of a broader industry pattern in the available data.
Real-World Impact
Clinicians and patients may face procedure delays and potential surgical complications. A prompt stop-use and recall follow-through are essential.
Practical Guidance
How to identify if yours is affected
- Check if the REF matches any listed in the recall notice
- Inspect packaging for the device type: DuraMax 16F chronic hemodialysis catheter with dual-valved sheath introducer
Where to find product info
On device labels, packaging, hospital procurement documents, and the FDA recall page linked in the notice.
What timeline to expect
Refunds or replacements typically complete within 4-8 weeks after qualification and authorization.
If the manufacturer is unresponsive
- Escalate to hospital infection control or medical device compliance team
- File a complaint with the FDA recall program if applicable
- Document all communications and responses
How to prevent similar issues
- Verify recalls before stocking devices for dialysis access
- Require updated lot/UDI documentation in purchasing
- Use approved vendor catalogs and current recalls checklists
Documentation advice
Keep photos of the device label, packaging, and recall notice. Save correspondence with Merit Medical and hospital procurement.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 21,591 units recalled worldwide
- Device uses a 16F dual-valved splittable sheath introducer
- Defect may prevent splitting as intended, risking hemorrhage and foreign bodies
- No injuries or incidents have been reported to date
- Recall includes numerous REF numbers and worldwide distribution including all US states
- FDA recall number Z-1578-2026
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.