Is this recall related to all CentrosFLO catheters or only specific models?

The recall covers a range of REF designations listed in the notice. Healthcare providers should verify whether their exact model is included by checking the recall documentation.

What is the defect and how does it affect use?

The 16F dual-valved splittable sheath introducer may not split as intended, which can cause hemorrhage, formation of foreign bodies, or delays during dialysis procedures.

What should I do if I own one of these devices?

Stop using the device immediately. Follow the recall instructions from Merit Medical Systems or your supplier and contact Merit for guidance on replacement or refund.

Are there any reported injuries or deaths from this recall?

No injuries or incidents have been reported in the data provided.

How long does the refund or replacement take?

Merit Medical typically provides a timeline through the recall process; organizations estimate 4-8 weeks for refunds or replacements after verification.

Where can I find the official recall notice?

The FDA enforcement page contains the official recall notice and details.

Will Merit replace the device or issue a refund?

The recall includes replacement or refund as options per Merit Medical's recall instructions.

Should healthcare facilities continue to use other CentrosFLO products?

Only devices not listed in the recall should continue to be used per facility policy.

Who should I contact for more information?

Contact Merit Medical Systems or your healthcare provider for instructions and next steps.

What identifiers help determine if a device is affected?

Model numbers from the recall listing and corresponding REF/UDI codes on packaging and labeling.

HIGHFebruary 13, 2026

Merit Medical CentrosFLO Hemodialysis Catheters Recalled for 35,591 Units (2026)

Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.

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

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

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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.

Real-World Impact

Hospitals and clinics must pause use of affected devices. Potential patient safety risks include bleeding, surgical complications, and treatment delays, with possible financial and operational burdens for facilities.

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.

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

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

BURNLACERATIONELECTRICALSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeSplittable sheath introducer (16F dual-valved) used with CentrosFLO Hemodialysis Catheters

Product Details

Dec 4, 2025

Merit Medical Systems

Inflation device