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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

582

Class I (Serious)

91

Most Recent

Dec 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 8901–8920 of 10937 recalls

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Prelude Short Sheath Introduc...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Futura Safety Scalpels, Futur...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog ...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

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Merit Medical Systems, Inc.: Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: ...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Prelude Short Sheath Introduc...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Monarch Inflation Syringe lab...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical GmbH, Unomedical Ltd., Catheter Fixation De...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

General Electric Medical Systems Information Technology: GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH wit...

Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH Transceiver can operate with the ApexPro FH Xpod connected, but without ECG lead wires attached to the transceiver. This is unintended use of the device that is not do

FDASep 25, 2009Nationwide• General Electric Medical Systems Information Technology

Quest Juice Dispensers (IMI Cornelius) – fire hazard (2009)

The recalled commercial juice dispensers have two or four dispensing valves with an illuminated or opaque rounded front cover. Dispensers with serial numbers starting with the following characters are included in this recall: 62A0522JT to 62A0540JT 62E0416JT to 62E0441JT 62F0425JT to 62F0453JT 62F0502JT to 62F0553JT 62F0601JT to 62F0631JT 72A0107JT to 72A0148JT 72A0303JT to 72A0350JT 72B0149JT to 72B0151JT 72B0202JT to 72B0252JT 72B0301JT to 72B0351JT 72C0305JT to 72C0352JT 72C0402JT to 72C0413JT 72D0345JT to 72D0353JT 72D0402JT to 72D0413JT 72E0414JT to 72E0424JT 72A0202JT The serial number can be found on the inside of the front door of the dispenser.

CPSCSep 24, 2009Nationwide• IMI Cornelius, of Osseo, Minn.

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter label reading in part: "CARDIOV...

Spontaneous balloon rupture during use of the product.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Edwards Lifesciences Research Medical, Inc.: EndoClamp aortic catheter. Label reading in part: "***CAR...

Balloon catheters were spontaneously rupturing during use.

FDASep 24, 2009Nationwide• Edwards Lifesciences Research Medical, Inc.

Ventana Medical Systems Inc: VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PR...

Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.

FDASep 17, 2009Nationwide• Ventana Medical Systems Inc

Toshiba American Medical Systems Inc: SSH-880CV Aplio Artida System

Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI

FDASep 16, 2009Nationwide• Toshiba American Medical Systems Inc

Varian Medical Systems Oncology Systems: VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers...

Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.

FDASep 15, 2009AL, FL, IL +8 more• Varian Medical Systems Oncology Systems

Boston Scientific CRM Corp: Boston Scientific, LATITUDE Communicator, Distributed by ...

Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test will not be displayed for physician review

FDASep 10, 2009Nationwide• Boston Scientific CRM Corp

Medtronic Inc. Cardiac Rhythm Disease Managment: This device is not approved in the United States. Medtron...

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

FDASep 9, 2009ID, WY• Medtronic Inc. Cardiac Rhythm Disease Managment

Medtronic Inc. Cardiac Rhythm Disease Managment: Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable ...

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

FDASep 9, 2009ID, WY• Medtronic Inc. Cardiac Rhythm Disease Managment

Medtronic Inc. Cardiac Rhythm Disease Managment: Medtronic Virtuoso VR, Model D154VWC, Single Chamber impl...

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

FDASep 9, 2009ID, WY• Medtronic Inc. Cardiac Rhythm Disease Managment

Medtronic Inc. Cardiac Rhythm Disease Managment: Medtronic Concerto, C154DWK, Dual chamber implantable car...

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

FDASep 9, 2009ID, WY• Medtronic Inc. Cardiac Rhythm Disease Managment

Medtronic Inc. Cardiac Rhythm Disease Managment: This device is not approved in the United States. Medtron...

A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

FDASep 9, 2009ID, WY• Medtronic Inc. Cardiac Rhythm Disease Managment