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Merit Medical Systems Recalls
145 recalls on record · November 14, 2012 to June 24, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a pa
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Waste Management Kit. Catalog Number K10-04381AP
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Manifold Kit. Catalog Number K09-11867AP
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
November 30, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Fluid Management Set. Catalog Number K08-MP5159A
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
October 12, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Inflation Syringe Kit. Catalog Number KOS-02857
Hazard: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
April 20, 2016Medical DevicesFDA
Merit Medical Systems, Inc. recalls Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatri
Hazard: 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 configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve
August 19, 2015Medical DevicesFDA
Merit Medical Systems, Inc. recalls ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids fro
Hazard: 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 actual device in the package.
July 1, 2015Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath I
Hazard: 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 PR0-6F-11-038.
November 12, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened
Hazard: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
April 30, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (10
Hazard: Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3
April 30, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102
Hazard: 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 a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.
April 9, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Hazard: The products are labeled as sterile but were not sterilized.
April 9, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer
Hazard: The products are labeled as sterile but were not sterilized.
February 26, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Cu
Hazard: Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax.
February 5, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Mer
Hazard: 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 depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There
January 8, 2014Medical DevicesFDA
Merit Medical Systems, Inc. recalls Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and
Hazard: 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 graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
October 30, 2013Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Hazard: 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
July 10, 2013Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medi
Hazard: 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 on the package resulting in a potential breach of the sterility of this accessory.
June 5, 2013Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be u
Hazard: Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
February 27, 2013Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile w
Hazard: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
January 16, 2013Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a co
Hazard: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
December 12, 2012Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom proce
Hazard: 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 contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
November 14, 2012DrugsFDA
Merit Medical Systems, Inc recalls Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8
Hazard: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.