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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

117

Past Year

Class I (Serious)

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 101–117 of 117 recalls

Merit Medical Systems, Inc: Merit Custom Procedure Kit

Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.

FDASep 2, 2005MD, OR, VA +1 more• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Custom Convenience Kit

Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use.

FDAOct 15, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Safety Paracentesis Procedure Tray

Merit Safety Paracentesis Procedure Trays contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use.

FDA

1...4 56

Page 6 of 6Next

Oct 15, 2004

Nationwide

• Merit Medical Systems, Inc

Merit Medical Systems, Inc: 8 ml Inject8 Coronary Control Syringe, sterile.

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: 10 ml Inject 10 Palm Pad, sterile

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Convenience Kits containing Inject8 or Inject10 syringes.

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

FDASep 14, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Merit MAK Mini Access Kit, 4 French (1.3mm)

Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

FDAJul 20, 2004Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm,...

Angiographic catheter tips may separate during use.

FDANov 5, 2003FL, MI, NY +4 more• Merit Medical Systems, Inc

Merit Medical Systems, Inc: UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiograph...

Angiographic catheter tips may separate during use.

FDANov 5, 2003FL, MI, NY +4 more• Merit Medical Systems, Inc

Merit Medical Systems, Inc: VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60...

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: IntelliSystem25 Inflation Device and Fluid Dispensing Syr...

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Waste Collection Kit. Label reads in part: ''CUSTOM KIT...

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Inflation Kit. Label reads in part: ''CUSTOM KIT...MERI...

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Monarch Inflation Device and Fluid Dispensing Syringe - L...

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Manifold Custom Kit. Label reads in part: ''CUSTOM KIT....

FDAOct 1, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Inject 10 Coronary Control Syringe (CCS), 10ml

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

FDAMay 16, 2003Nationwide• Merit Medical Systems, Inc

Merit Medical Systems, Inc: Custom Kit

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

FDAMay 16, 2003Nationwide• Merit Medical Systems, Inc