Is this device recalled and what is the scope of the recall?

Yes. Merit Medical Systems issued a recall for BioFlo DuraMax Catheters globally due to a design defect in the 16F dual-valved splittable sheath introducer. The recall covers 47,153 units distributed worldwide.

Which model numbers are included in the recall?

The recall includesREF numbers such as H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, and others listed by Merit Medical Systems.

What is the hazard associated with the device?

The 16F dual-valved splittable sheath introducer may not split as intended, which may lead to hemorrhage, foreign bodies, and delays in the procedure.

What should I do if I own or use this device?

Stop using the product immediately. Then contact Merit Medical Systems or your healthcare provider for instructions. Do not attempt to use the device again unless cleared by a professional.

Are there any reported injuries from this recall?

No injuries or incidents have been reported at this time.

How can I determine if my device is affected?

Compare the device REF numbers on the label to the list provided by Merit Medical Systems. Consult your healthcare provider for confirmation.

Will I receive a refund or replacement?

Merit Medical Systems will provide recall instructions that may include replacement or other remedies. Contact Merit or your healthcare provider for specifics.

Where can I find more information about this recall?

Visit Merit Medical Systems' site at merit.com and the FDA recall page at the provided enforcement link.

What is the typical timeline for a remedy?

The recall notice does not specify a timeline. Treatment and replacement will be guided by Merit Medical Systems and healthcare providers.

Who is affected by this recall?

Patients and healthcare providers using the BioFlo DuraMax Catheter with the 16F dual-valved sheath introducer are affected.

How should I report a potential adverse event?

If you experience a problem, report it to the healthcare provider and consider reporting to the FDA via its MedWatch system.

What should I do with the recalled devices?

Follow the manufacturer’s instructions for disposal or return as directed in the recall notice.

HIGHFebruary 13, 2026

Merit Medical BioFlo DuraMax Catheter Recall 2026: 47,153 Units Worldwide

Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit

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

The BioFlo DuraMax Catheter is used to access blood vessels during vascular procedures. The recall concerns a splittable sheath introducer used in the device's delivery system during catheter placement.

Why This Is Dangerous

A design defect may prevent the sheath introducer from splitting as intended, which can lead to hemorrhage or foreign bodies and cause delays in the procedure.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Hospitals and clinics may need to replace affected devices promptly. The recall emphasizes stopping use and following manufacturer guidance to protect patient safety.

Practical Guidance

How to identify if yours is affected

Review device label for REF numbers and compare to the recall list.
Check any UDI or lot numbers if available.
Consult your hospital or clinician to confirm whether the device is affected.

Where to find product info

Visit merit.com or the FDA recall page linked in the notice for official identifiers and instructions.

What timeline to expect

The recall notice does not specify a replacement or refund timeline.

If the manufacturer is unresponsive

Escalate to the hospital recall coordinator.
Contact Merit Medical Systems directly for guidance.
File a report with the FDA if you suspect an adverse event.

How to prevent similar issues

Verify recall status before using any vascular sheath introducer.
Maintain an updated inventory of devices and batch numbers.
Check supplier notices and FDA recall announcements regularly.

Documentation advice

Keep copies of the recall notice, device labels with REF numbers, and all communications with Merit Medical Systems or healthcare providers. Photograph labels if needed.

Product Details

Quantity: 47,153 units. Distribution: Worldwide. US distribution includes TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV. Countries: Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, United Kingdom, Brunei, Ecuador, Panama,,

Reported Incidents

No injuries or incidents have been reported.

Key Facts

47,153 total units recalled
Global distribution including US states and international markets
REFs include H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU,
16F dual-valved splittable sheath introducer with design defect
Remedy requires stopping use and following manufacturer instructions

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHERLACERATION

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product Type16F dual-valved splittable sheath introducer

Product Details

Dec 4, 2025

Merit Medical Systems

Inflation device