Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Merit Medical Recalled by Merit Medical Systems, Inc. Due to Inflation device handle may detach from the syringe...

Date: December 4, 2025
Company: Merit Medical Systems, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.

Affected Products

Merit Medical , Custom Manifold Kit REF: K09-13203A

Quantity: 2192 units

Why Was This Recalled?

Inflation device handle may detach from the syringe during procedure.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Merit Medical Systems, Inc.

Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report