Merit Medical Systems, Inc. Recalls

All product recalls associated with Merit Medical Systems, Inc..

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Recall Summary

Total Recalls

117

Past Year

9

Class I (Serious)

1

Most Recent

Aug 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 117 recalls

PhD Hemostasis Valve (Merit Medical) – manufacturing defect (2025)

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

FDAAug 4, 2025AL, AK, AZ +47 more• Merit Medical Systems, Inc.

10Fore Hemostasis Valve (Merit Medical) – Silicone Ring Defect (2025)

Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.

FDAJul 25, 2025Nationwide• Merit Medical Systems, Inc.

Custom Tubing Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

FDA

Jun 5, 2025

Nationwide

• Merit Medical Systems, Inc.

Custom Waste Management Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

High Pressure Tubing (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

Custom Manifold Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

FDAMar 14, 2025Nationwide• Merit Medical Systems, Inc.

Prelude IDEAL Sheath Introducer (Merit) – incorrect dilator (2025)

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

FDAJan 27, 2025Nationwide• Merit Medical Systems, Inc.

Melrose Injector (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Monarch Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.