The Recall Desk

Manufacturer

Merit Medical Systems, Inc.

145 recalls in our database name Merit Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
145
Critical
1
Severe
9
Most recent
2026-06-24

Of the 145 recalls from Merit Medical Systems, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (6%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–145 of 145

  • ModerateFDA (Devices)·Z-0649-2017·2016-11-30

    Merit Medical Recalls Fluid Administration Sets Due to Molding Defect

    Merit Medical Systems is voluntarily recalling 107,341 Fluid Administration Sets due to a molding defect in the drip chamber.

    Product
    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2017·2016-10-12

    Merit Medical Recalls Inflation Syringe Kits Due to Labeling Errors

    Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.

    Product
    Merit Inflation Syringe Kit. Catalog Number KOS-02857
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1375-2016·2016-04-20

    Merit Medical Recalls TSX Transseptal Needle Due to Labeling Error

    Merit Medical Systems is recalling one lot of TSX Transseptal Needles because the packaging labels incorrectly state a 50-degree curve instead of the actual 86-degree curve.

    Product
    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2352-2015·2015-08-19

    Merit Medical Recalls ReSolve Locking Drainage Catheters Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling 950 ReSolve Locking Drainage Catheters because the unit labeling may not match the actual device in the package.

    Product
    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1826-2015·2015-07-01

    Merit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging

    Merit Medical Systems is recalling Prelude Pro Sheath Introducers packaged with a 0.035-inch dilator instead of the labeled 0.038-inch size.

    Product
    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0162-2015·2014-11-12

    Merit Maestro Microcatheter Recalled for Incorrect Distal Tip Size

    Merit Medical Systems is recalling 56 Maestro Microcatheters because they were packaged with a 2.8 F distal tip instead of the labeled 2.4 F.

    Product
    Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2014·2014-04-30

    Merit Medical Recalls Hydrophilic Guide Wires Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling specific lots of Laureate Hydrophilic Guide Wires due to a discrepancy between carton and unit labeling.

    Product
    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2014·2014-04-30

    Merit Medical Recalls Mixed Hydrophilic Guide Wire Lots

    Merit Medical Systems is recalling 173 units of Laureate Hydrophilic Guide Wire due to a labeling discrepancy where the product was mixed with a different lot.

    Product
    Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1320-2014·2014-04-09

    Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits

    Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.

    Product
    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2014·2014-04-09

    Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

    Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

    Product
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2014·2014-02-26

    Merit Medical Recalls Custom Procedural Trays Contaminated with Particulate Matter

    Merit Medical Systems is recalling custom procedural trays containing 1% Lidocaine HCl injection due to visible particulate matter found in the product container.

    Product
    Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0901-2014·2014-02-05

    Merit Medical Systems Recalls RAD BOARD Devices Due to Missing Labels

    Merit Medical Systems is voluntarily recalling one lot of RAD BOARD devices because missing labels may allow incorrect orientation, potentially obscuring patient anatomy during fluoroscopy.

    Product
    Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patie
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0614-2014·2014-01-08

    Merit Medical Systems Recalls Maestro Microcatheters Due to Label Graphic Discrepancy

    Merit Medical Systems is recalling 59 Maestro Microcatheters because the graphic on the carton's end panel does not match the front panel.

    Product
    Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, emb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2014·2013-10-30

    Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation

    Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.

    Product
    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1660-2013·2013-07-10

    Merit Medical Systems Recalls Custom Angio Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 134 custom angio kits because a missing seal may compromise the sterility of the hand controller sheaths.

    Product
    Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are h
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1408-2013·2013-06-05

    Merit Medical Recalls Performa Cardiac Multipacks Due to Tip Shape Variation

    Merit Medical Systems is recalling specific lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

    Product
    Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2013·2013-02-27

    Merit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage

    Merit Medical Systems is recalling 387 Resolve Biliary Locking Drainage Catheters because a consumer reported the device broke into several pieces during use.

    Product
    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0663-2013·2013-01-16

    Merit Medical Recalls Custom Procedural Trays Due to Particulate Matter

    Merit Medical Systems is recalling 422 Custom Procedural Trays and Kits because of particulate matter found in the 0.9% Sodium Chloride Injection.

    Product
    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended use
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0464-2013·2012-12-12

    Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape

    Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.

    Product
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-040-2013·2012-11-14

    Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits

    Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.

    Product
    Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
    Category
    Medical Device
    Distribution
    4 states