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 Procedure Kit
- Model numbers
- Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055
- 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 Merit Medical Custom Procedure Kit is used in various medical procedures requiring inflation. Healthcare providers buy these kits for their essential role in patient treatment.
Why This Is Dangerous
The handle of the inflation device can detach from the syringe, which could lead to complications during procedures. This defect puts patients at risk of receiving inadequate or improper treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the affected kits, which may disrupt medical procedures and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Locate the reference number on the kit packaging.
- Verify if the reference number is K12T-04270A, K12T-07956, or K12T-10922B.
- Check for the lot number associated with your kit.
Where to find product info
The reference numbers and lot numbers are typically printed on the kit packaging and product labeling.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after the request is submitted.
If the manufacturer is unresponsive
- Keep records of your communication attempts with the company.
- Consider contacting the FDA for further guidance if you do not receive a response.
How to prevent similar issues
- Look for safety certifications when purchasing medical devices.
- Choose products from reputable manufacturers with established safety records.
- Be cautious of recalls and check for safety alerts regularly.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any photos of the product as evidence for your records.
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Product Details
The recall includes Custom Procedure Kits with reference numbers K12T-04270A, K12T-07956, and K12T-10922B. These kits were distributed worldwide, including in all U.S. states and numerous countries. Specific lot numbers are listed for each reference number.
Key Facts
- Recall date: December 4, 2025
- High hazard level due to potential injury risk
- Affected reference numbers: K12T-04270A, K12T-07956, K12T-10922B
- Worldwide distribution, including the U.S. and various countries
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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