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
- Splittable sheath introducer (16F dual-valved) used with CentrosFLO Hemodialysis Catheters
- Model numbers
- REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122, CENFP15K/B: CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123, CENFP19K/A:00884450200018/H2415318, H2466455 +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
CentrosFLO Hemodialysis Catheters are used to provide vascular access for hemodialysis. The recall concerns the integration of a splittable sheath introducer used during catheter placement.
Why This Is Dangerous
A defect in the 16F dual-valved introducer may prevent splitting as designed, increasing risks of hemorrhage, retained foreign bodies, and delays during dialysis procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the data provided.
Practical Guidance
How to identify if yours is affected
- 1. Review device REF numbers and UDI codes listed in the recall notice.
- 2. Compare with labels on your CentrosFLO catheter and introducer components.
- 3. If matched, discontinue use immediately and remove from service under medical guidance.
Where to find product info
FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1575-2026
What timeline to expect
Likely 4-8 weeks for refunds or replacements after verification, depending on Merit Medical processing and facility readiness.
If the manufacturer is unresponsive
- Document all communications with Merit Medical and suppliers
- File a formal complaint with the appropriate regulatory body if the vendor is unresponsive
- Consult hospital risk management and legal counsel if needed
How to prevent similar issues
- Purchase and store devices from authorized distributors only
- Regularly check recall databases and manufacturer alerts
- Maintain an up-to-date inventory of all vascular access devices
- Verify model numbers before use and during recalls
- Educate procurement and clinical staff on recall procedures
Documentation advice
Keep packaging, labels, serial numbers, recall notices, and all correspondence with Merit Medical or suppliers. Photograph affected serial numbers and store receipts.
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Product Details
Quantity recalled: 35,591 units. Distribution: Worldwide; US distribution to multiple states listed; international distribution to Canada, Spain, United Arab Emirates, Brazil, and more. Recall date: 2026-02-13. Report date: 2026-04-01. Brand: Merit Medical Systems. Product: CentrosFLO Hemodialysis Catheters with 16F dual-valved splittable sheath introducer (REFs listed) and related lot/UDI identifiers.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall affects 35,591 units
- Products distributed worldwide including US states and many countries
- Hazard: hemorrhage, foreign-body risk, procedure delay
- No injuries or incidents reported yet
- Immediate stop-use advised; seek manufacturer guidance
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Safety Guide
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