Quick Facts at a Glance
- Recall Date
- December 4, 2025
- 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
- Custom Waste Management Kit Vascular Tray
- Model numbers
- UDI: 00884450320297/ Lot: T2736369 T2781930 T2898771S T3047503 T3090431 T3121937 T3146114 T3158708 T3204129 T3232415
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Inflation device handle may detach from the syringe during procedure.
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. Notification method: E-Mail
About This Product
The Custom Waste Management Kit Vascular Tray is used in medical procedures to manage waste safely. Healthcare providers rely on this device to ensure proper handling during vascular interventions.
Why This Is Dangerous
The inflation device's handle detaching from the syringe can interrupt procedures, leading to potential complications and risks for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act promptly to avoid complications from using the recalled device.
Practical Guidance
How to identify if yours is affected
- Check the model number on the product packaging.
- Verify the UDI against the recall notice.
- Consult your healthcare provider if unsure about the product.
Where to find product info
The model number and UDI can typically be found on the product label or packaging.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Keep a record of all communications with the manufacturer.
- Reach out to the FDA for assistance in resolving the issue.
How to prevent similar issues
- Regularly check for product recalls before using medical devices.
- Purchase only from reputable suppliers that provide safety information.
Documentation advice
Document all correspondence regarding the recall and keep any packaging or labels as evidence.
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Product Details
The recalled product is the Custom Waste Management Kit Vascular Tray, REF: K10T-05261. It was distributed worldwide, including all U.S. states and several countries. The model is identified by UDI: 00884450320297.
Key Facts
- Hazard: Handle may detach during use
- Affected model REF: K10T-05261
- Worldwide distribution including U.S. and multiple countries
- Class II recall
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Safety Guide
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