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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 21–40 of 117 recalls

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.

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

7F sheath introducers labeled as 7.5F

FDAAug 12, 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.

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Merit Medical Convenience Kits (Merit Medical) - Syringe Issues (2024)

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.

FDAJun 11, 2024Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5...

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.

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (...

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

FDAMar 14, 2024Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST...

The sterility of microcatheter and infusion system devices cannot be guaranteed.

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEE...

The sterility of microcatheter and infusion system devices cannot be guaranteed.

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Maestro Microcatheter, Reference Numbers: 28MC2111...

The sterility of microcatheter and infusion system devices cannot be guaranteed.

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, RE...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-1...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile ...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F,...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E0...

Custom sheath Introducer contains incorrect needle size

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE...

Product that was built for design verification testing was inadvertently distributed to customers.

FDAFeb 15, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610...

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

FDAAug 3, 2022AL, AK, AZ +40 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 58...

A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.

FDAMar 1, 2022AL, AK, AZ +46 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Access-9 Large Bore Hemostasis Valves, Catalog Code: 5807...

FDAMar 1, 2022AL, AK, AZ +46 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F...

There is a potential that a package sheath contains an incorrect dilator.

FDAJul 21, 2021Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Prelude SNAP Splittable Sheath Introducer, REF: PLSX -101...

There is a potential that 7F sheaths are packaged as 10F sheaths.

FDAJun 30, 2021AL, AR, CA +26 more• Merit Medical Systems, Inc.