HIGH

Merit Medical 16F Dual-Valved Splittable Sheath Introducer Recalled for 368,264 Units Worldwide (202

Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for 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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

The device is a 16F dual-valved splittable sheath introducer used in vascular access procedures. It is sold worldwide to healthcare providers in bulk formats. The recall concerns a design defect that could affect procedural outcomes and patient safety.

Why This Is Dangerous

If the sheath does not split as designed, there is a risk of bleeding, retained foreign material, and delays in procedures.

Industry Context

This recall is not part of a broader industry pattern of device failures. It involves a single product line from a single manufacturer.

Real-World Impact

Clinicians may experience complications during vascular access procedures, potentially affecting patient safety and leading to product replacement or procedural delays.

Practical Guidance

How to identify if yours is affected

  1. 1. Locate device label: REF: FCL-174-00/B
  2. 2. Review lot/UDI numbers
  3. 3. Compare to the model list provided in recall materials
  4. 4. If uncertain, treat as affected and discontinue use

Where to find product info

Device labels, packing, and Merit Medical recall notices; FDA recall enforcement page

What timeline to expect

4-8 weeks for refunds or replacements after validation

If the manufacturer is unresponsive

  • Document all communications
  • File a consumer complaint with the FDA if the company remains unresponsive
  • Consider seeking legal counsel for serious injury claims

How to prevent similar issues

  • Verify device recalls before procurement
  • Use only devices from authorized suppliers
  • Maintain an updated supplier recall database

Documentation advice

Keep order records, serial numbers, photos of the device, and all recall correspondence for reference

Product Details

Product: 16F Dual-Valved Splittable Sheath Introducer (bulk, non-sterile) REF: FCL-174-00/B. Manufacturer: Merit Medical Systems. Quantity recalled: 368,264 units. Sold worldwide with U.S. distribution to multiple states and international distribution to numerous countries. Recall date: 2026-02-13. Status: ACTIVE. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity recalled: 368,264 units
  • Product: 16F Dual-Valved Splittable Sheath Introducer
  • Class I recall; hazard level HIGH
  • Worldwide distribution; U.S. states listed; international country list provided
  • REF: FCL-174-00/B
  • Remedy: stop use immediately; contact Merit Medical for instructions
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

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 Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Type16F Dual-Valved Splittable Sheath Introducer
Sold At
Multiple Retailers

Product Details

Model Numbers
REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705
I2370091
I2370711
I2370712
I2377840
+15 more
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Merit Medical ProGuide 16F Dialysis Sheath Introducer Recalled Worldwide in 2026 (131 Units)

Merit Medical Systems recalled 131 units of the ProGuide chronic dialysis catheter introducer worldwide after a design defect could prevent the device from splitting as intended. The defect may cause hemorrhage, retained foreign bodies, and delays to procedures. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

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

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

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.

Merit Medical Systems
16F dual-valved
Read more
Health & Personal Care
HIGH

Merit Medical Recalls Inflation Kits Due to Handle Detachment Hazard

Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
Read more
Health & Personal Care
HIGH

Merit Medical Inflation Device Recalled Over Handle Detachment Risk

Merit Medical Systems recalled 4,163,123 inflation devices on December 4, 2025, due to a risk that the handle may detach during use. This defect poses a high hazard to patients and healthcare providers. Consumers should stop using the device immediately and follow the manufacturer’s instructions for returns.

Merit Medical Systems
Inflation device
Read more
Health & Personal Care
HIGH

Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard

Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.

Merit Medical Systems
Inflation device
Read more
Health & Personal Care
HIGH

Merit Medical Systems Recalls Angioplasty Packs Over Detachment Hazard

Merit Medical Systems recalled 328,000 angioplasty packs on December 4, 2025, due to a risk of the inflation device handle detaching during procedures. The recall affects devices distributed worldwide, including states across the U.S. Healthcare providers and patients must stop using the devices immediately.

Merit Medical Systems
Inflation device
Read more