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: FCL-174-00/B:00884450522196/I2362705, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290 +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
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. Locate device label: REF: FCL-174-00/B
- 2. Review lot/UDI numbers
- 3. Compare to the model list provided in recall materials
- 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
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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
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Safety Guide
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