HIGH

Merit Medical Recalls Custom Manifold Kit Due to Detachment Risk

Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

  1. Check the product label for REF: K09-13203A.
  2. Verify if your kit matches the listed lot numbers: H2671718, H2681531, etc.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

Related Recalls

Vehicles & Parts
HIGH

Mazda CX-70 Recall 2025 for Powertrain Control Module Software May Lose Drive Power

Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.

Mazda
Loss of
Read more
Vehicles & Parts
HIGH

Nissan Kicks 2025 Certification Label Recall for GVWR/GAWR Errors (PD136, PMA47)

Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.

Nissan
An overloaded
Read more