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(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030, H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023 +12 more
- Sizes
- 16F
- 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 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.
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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
- 16F dual-valved splittable sheath introducer with design defect
- Remedy requires stopping use and following manufacturer instructions
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Safety Guide
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