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 Manifold Kit
- Model numbers
- K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407
- 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 Manifold Kit is a medical device used in various healthcare procedures requiring syringe inflation. It is commonly utilized in environments like hospitals and clinics for patient care.
Why This Is Dangerous
The inflation handle detachment poses a risk during medical procedures, potentially leading to complications or inadequate treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to ensure safety and avoid complications during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the product label for REF: K09-13203A.
- Verify if your kit matches the listed lot numbers: H2671718, H2681531, etc.
- Consult your healthcare provider for verification.
Where to find product info
Look for the REF number and lot numbers on the product packaging or accompanying documentation.
What timeline to expect
Expect refund processing to take approximately 4-8 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Contact consumer protection agencies for assistance.
How to prevent similar issues
- Research medical device safety records before purchasing.
- Look for FDA-approved or certified devices.
- Choose products from reputable manufacturers.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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Product Details
The recalled product is the Custom Manifold Kit, REF: K09-13203A. It has been distributed worldwide, including all U.S. states and several international countries. Specific lot numbers include H2671718, H2681531, H2758436, H2792533, H2796074, H3046979, H3052442, H3147779, H3246149, H3254530, and H3297407.
Key Facts
- Recalled product: Custom Manifold Kit, REF: K09-13203A
- Quantity recalled: 2,192 units
- Affected states: All U.S. states and multiple countries
- Hazard: Handle may detach during use
- Classification: Class II recall
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Safety Guide
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