Merit Medical Systems, Inc. recalls
61 recalls in our records from 2012 to 2026: 60 FDA medical devices, 1 FDA drugs.
Recalls with full detail pages
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Merit Medical Systems, Inc. medical device recall: CentrosFLO Hemodialysis Catheters
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay,…
Earlier and other recalls
These link to the official agency notice.
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Merit Medical Systems, Inc. medical device recall: Scout MD Official notice ↗
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
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Merit Medical Systems, Inc. medical device recall: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam Official notice ↗
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile…
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Merit Medical Systems, Inc. medical device recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes:… Official notice ↗
Due to unsealed portions of pouches.
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Merit Medical Systems, Inc. medical device recall: Philips Bridge Prep Kit REF: K12-09098B Sterile EO Official notice ↗
catheter may experience resistance when being advanced over the guidewire
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Merit Medical Systems, Inc. medical device recall: Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference… Official notice ↗
Inflation device handle may detach from the syringe during procedure.
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Merit Medical Systems, Inc. medical device recall: PhD Hemostasis Valve Official notice ↗
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience…
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Merit Medical Systems, Inc. medical device recall: 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 /… Official notice ↗
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
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Merit Medical Systems, Inc. medical device recall: High Pressure Tubing: REF: 502211002 Official notice ↗
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected…
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Merit Medical Systems, Inc. medical device recall: Merit Medical Official notice ↗
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
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Merit Medical Systems, Inc. medical device recall: Prelude IDEAL 4 F Hydrophilic Sheath Introducer Official notice ↗
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
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Merit Medical Systems, Inc. medical device recall: Blue Diamond Digital Inflation Device Official notice ↗
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…
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Merit Medical Systems, Inc. medical device recall: Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe Official notice ↗
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
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Merit Medical Systems, Inc. medical device recall: Prelude Sheath Introducer 7.5F Official notice ↗
7F sheath introducers labeled as 7.5F
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Merit Medical Systems, Inc. medical device recall: Various Merit Medical convenience kits that contain recalled Jiangsu… Official notice ↗
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…
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Merit Medical Systems, Inc. medical device recall: Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP… Official notice ↗
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…
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Merit Medical Systems, Inc. medical device recall: Prelude Guide Sheath Roadster Official notice ↗
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
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Merit Medical Systems, Inc. medical device recall: Merit Maestro Microcatheter Official notice ↗
The sterility of microcatheter and infusion system devices cannot be guaranteed.
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Merit Medical Systems, Inc. medical device recall: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F Official notice ↗
There is a potential that valve assemblies will not open. preventing fluid from draining.
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Merit Medical Systems, Inc. medical device recall: Cobra-Os Official notice ↗
Custom sheath Introducer contains incorrect needle size
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Merit Medical Systems, Inc. medical device recall: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A Official notice ↗
Product that was built for design verification testing was inadvertently distributed to customers.
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Merit Medical Systems, Inc. medical device recall: CorVocet Biopsy System/Catalog Code: CORA1610/B Official notice ↗
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…
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Merit Medical Systems, Inc. medical device recall: Access-9 Large Bore Hemostasis Valves Official notice ↗
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,…
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Merit Medical Systems, Inc. medical device recall: MERITMEDICAL Prelude Short Sheath Introducer Official notice ↗
There is a potential that a package sheath contains an incorrect dilator.
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Merit Medical Systems, Inc. medical device recall: Prelude SNAP Splittable Sheath Introducer Official notice ↗
There is a potential that 7F sheaths are packaged as 10F sheaths.
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Merit Medical Systems, Inc. medical device recall: basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to… Official notice ↗
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
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Merit Medical Systems, Inc. medical device recall: HeartSpan Transseptal Needles Catalog No. FND-019-01 Official notice ↗
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is…
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Merit Medical Systems, Inc. medical device recall: Product Code: K05T-02533 Official notice ↗
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to…
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Merit Medical Systems, Inc. medical device recall: MeritMedical Cultura Flex Swab Official notice ↗
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal…
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Merit Medical Systems, Inc. medical device recall: DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly Official notice ↗
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the…
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Merit Medical Systems, Inc. medical device recall: Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended… Official notice ↗
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in…
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Merit Medical Systems, Inc. medical device recall: PreludeSYNC DISTAL Radial Compression Devices Official notice ↗
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain…
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Merit Medical Systems, Inc. medical device recall: ChloraPrep With Tint Official notice ↗
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
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Merit Medical Systems, Inc. medical device recall: Custom Procedure Kit Official notice ↗
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
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Merit Medical Systems, Inc. medical device recall: Flex-Neck Classic Peritoneal Dialysis Catheter Official notice ↗
Mix-up between adult and pediatrics PD catheter.
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Merit Medical Systems, Inc. medical device recall: 1mL Medallion Syringes Are used to inject fluids into Official notice ↗
Supplier manufacturing defect with the syringe plunger tip.
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Merit Medical Systems, Inc. medical device recall: Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled Official notice ↗
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
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Merit Medical Systems, Inc. medical device recall: PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath… Official notice ↗
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the…
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Merit Medical Systems, Inc. medical device recall: 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001 Official notice ↗
Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
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Merit Medical Systems, Inc. medical device recall: The PreludeSYNC Radial Compression Device is a sterile Official notice ↗
Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing…
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Merit Medical Systems, Inc. medical device recall: 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070 Official notice ↗
Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may…
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Merit Medical Systems, Inc. medical device recall: PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit… Official notice ↗
Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and…
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Merit Medical Systems, Inc. medical device recall: Fluid Management Set. Catalog Number K08-MP5159A Official notice ↗
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
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Merit Medical Systems, Inc. medical device recall: Custom Fluid Management Set Official notice ↗
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
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Merit Medical Systems, Inc. medical device recall: Merit Inflation Syringe Kit. Catalog Number KOS-02857 Official notice ↗
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
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Merit Medical Systems, Inc. medical device recall: Boston Scientific TSX Transseptal Needle Official notice ↗
Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual…
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Merit Medical Systems, Inc. medical device recall: ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are… Official notice ↗
Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the…
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Merit Medical Systems, Inc. medical device recall: Merit Medical Prelude Pro Sheath Introducter Official notice ↗
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number…
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Merit Medical Systems, Inc. medical device recall: Merit Maestro Microcatheter Official notice ↗
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
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Merit Medical Systems, Inc. medical device recall: Merit Laureate Hydrophilic Guide Wire Official notice ↗
Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and…
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Merit Medical Systems, Inc. medical device recall: Pressure Monitoring Tubing Official notice ↗
The products are labeled as sterile but were not sterilized.
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Merit Medical Systems, Inc. medical device recall: Merit Medical's Custom Procedural Trays or Kits containing 1%… Official notice ↗
Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the…
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Merit Medical Systems, Inc. medical device recall: Radial Assist RAD BOARD Official notice ↗
Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically…
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Merit Medical Systems, Inc. medical device recall: Catheter Official notice ↗
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter…
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Merit Medical Systems, Inc. medical device recall: Merit Medical Performa Angiographic Catheter 5F Multipack. Part… Official notice ↗
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
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Merit Medical Systems, Inc. medical device recall: Custom Procedural Trays: Merit's Custom Angio Kits A custom… Official notice ↗
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing…
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Merit Medical Systems, Inc. medical device recall: Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product… Official notice ↗
Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
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Merit Medical Systems, Inc. medical device recall: Merit Medical Systems Inc Official notice ↗
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
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Merit Medical Systems, Inc. medical device recall: Merit Medical's Custom Procedural Tray or Kits K12T-03162B & Official notice ↗
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were…
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Merit Medical Systems, Inc. medical device recall: Custom Procedural Trays: Merit's Custom Total Hip Pack Official notice ↗
Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from…
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Merit Medical Systems, Inc drug recall: Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt… Official notice ↗
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.