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): DC01455550/C:00884450697870/H2600169, DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C /H2600164, H2628890, DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C/H2630602, DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229
- 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 ProGuide line includes chronic dialysis catheters and associated introducers used in vascular access procedures. Clinicians rely on these devices for timely, safe catheter insertion in dialysis patients.
Why This Is Dangerous
The 16F dual-valved splittable sheath introducer may fail to split as intended during use. This defect can cause hemorrhage, presence of foreign material, and delays in the procedure.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may face procedure delays and potential patient safety risks if affected introducers are used before replacement.
Practical Guidance
How to identify if yours is affected
- Review device packaging for model numbers and lot/UDI codes listed in the recall.
- Compare your stock against the recall identifiers to identify affected devices.
- Verify recall status with your procurement or supplier.
Where to find product info
Identifiers are printed on the device packaging and labeling. The FDA recall page provides the official list of identifiers.
What timeline to expect
Refunds or replacements are typically processed within weeks after verification and approval by the manufacturer.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement, and contact the FDA/CPSc if needed
- Document all communication and attempts to resolve the issue.
How to prevent similar issues
- Institute a recall-check protocol for all dialysis-related devices
- Verify UDI and lot codes before use or placement
- Rely on official manufacturer and FDA recall notices for any future actions
Documentation advice
Retain recall notice, purchase records, packaging, serial/lot numbers, and correspondence with Merit Medical or suppliers.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: 16F dual-valved splittable sheath introducer used with ProGuide Chronic Dialysis Catheters
- Manufacturer: Merit Medical Systems
- Recall number reference: Z-1576-2026 (FDA)
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Safety Guide
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