Merit Medical Systems, Inc.

58 FDA enforcement actions

58 Total Recalls

0 Class I

58 Class II

0 Class III

Firm Details

Product Types: device
States: UT

All Recalls

Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025 device

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 08/04/2025 device

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.
Class II: Risk 07/25/2025 device

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.
Class II: Risk 06/05/2025 device

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.
Class II: Risk 06/05/2025 device

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.
Class II: Risk 06/05/2025 device

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.
Class II: Risk 06/05/2025 device

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.
Class II: Risk 03/14/2025 device

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Class II: Risk 03/14/2025 device

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Class II: Risk 01/27/2025 device

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/30/2024 device

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/19/2024 device

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class II: Risk 08/12/2024 device

7F sheath introducers labeled as 7.5F
Class II: Risk 08/12/2024 device

7F sheath introducers labeled as 7.5F
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 06/11/2024 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 05/22/2024 device

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.