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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

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 61–80 of 117 recalls

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Prelude Pro Sheath Introducer...

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. Medallion Syringe 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 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.

Page 4 of 6Next

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 Advance Angiographic Needle label reading in part: ...

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. 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. 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 Systems, Inc., Convenience Trays, custom pa...

Surgical gloves in hospital convenience kits may be degraded and tear during use.

FDAMay 19, 2009CO, IN, TX• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 5F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude Short Sheath Introducer, Carolina Kidney and Endo...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 7F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 6F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: 8F Prelude Short Sheath Introducer, 4CM in Length with Ma...

External tubing may separate during use, allowing blood loss.

FDAApr 14, 2009CA, CO, GA +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, S...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Me...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: University Health System Custom Cardiac Cath Pack, K09T-0...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Meri...

A manufacturing defect may prevent adequate sterilization of the entire device.

FDAJan 29, 2009Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: ReSolve Hydophilic Coated Locking Biliary Catheter, REF R...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

FDANov 7, 2008Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: ReSolve Hydrophilic Coated Locking Biliary Catheter, REF ...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

FDANov 7, 2008Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Custom Waste Management Kit, K10-01756/B, Sterile EO, Mer...

Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.

FDASep 12, 2008Nationwide• Merit Medical Systems, Inc.