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Merit Medical Systems, Inc.

Merit Medical Systems, Inc. Recalls

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

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

22

Most Recent

Jan 2026

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 461–480 of 3680 recalls

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.

MultiDiagnost Eleva (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion System (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

1...22 232425 26...184

Page 24 of 184Next

FDA

Aug 22, 2024

Nationwide

• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

INTEGRIS Allura System (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper OR Table (PHILIPS) – Cable Hose Carrier Risk (2024)

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

FDAAug 22, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Blue Diamond Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

StabiliT TOUCH Syringe (Merit Medical) – Sterile Barrier Breach (2024)

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Custom Inflation Kit (Merit Medical) – Sterile Barrier Breach (2024)

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

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

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.

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Prelude Sheath Introducer (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

Custom Procedure Kit (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

Philips Allura Xper System (Philips) - Bolt Placement Error (2024)

A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

FDAAug 8, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Butter & Yeast Popcorn (Kester Foods) – Undeclared Milk (2024)

Label declares butter and ghee but does not declare milk.

Class IIModerate

FDAAug 8, 2024CA, IN, OR• Kester Foods LLC

Yummy Monkey Organics Popcorn (Kester Foods) – Undeclared Milk (2024)

Label declares butter and ghee but does not declare milk.

Class IIModerate

FDAAug 8, 2024CA, IN, OR• Kester Foods LLC

Neuro Vascular Kit (American Contract) - Humidity Control Failure (2024)

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

FDAAug 7, 2024Nationwide• American Contract Systems, Inc.