The Recall Desk

Manufacturer

Merit Medical Systems, Inc.

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

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.

26–50 of 93

  • HighFDA (Devices)·Z-0057-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect

    Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.

    Product
    Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2025·2024-10-23

    Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall

    Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.

    Product
    StabiliT TOUCH Syringe, REF: IN8VCF/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.

    Product
    Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2025·2024-10-23

    Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk

    Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.

    Product
    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0072-2025·2024-10-23

    basixTOUCH Inflation Device May Have Sterile Barrier Defect

    Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.

    Product
    basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2025·2024-10-23

    Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.

    Product
    basixSKY Inflation Device, REF: SKY1802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0061-2025·2024-10-23

    Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.

    Product
    Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2025·2024-10-23

    DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall

    Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.

    Product
    DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2025·2024-10-23

    MONARCH Inflation Device Recalled Due to Sterile Barrier Defect Risk

    Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.

    Product
    MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2025·2024-10-23

    BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk

    BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.

    Product
    BlueFIRE Inflation Device, REF: IN10140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2025·2024-10-23

    Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects

    Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.

    Product
    Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2025·2024-10-23

    Monarch Inflation Devices Recalled for Sterile Barrier Defects

    Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.

    Product
    Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2025·2024-10-23

    basixTOUCH Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.

    Product
    basixTOUCH Inflation Device, REF: IN8140/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2024·2024-10-02

    Prelude Sheath Introducer 7.5F devices recalled due to labeling error

    Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.

    Product
    Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2024·2024-10-02

    Custom Procedure Kit Sheath Introducers Mislabeled by Size

    Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.

    Product
    Custom Procedure Kit, REF: K12T-11077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2024·2024-08-21

    Merit Medical catheter extractor kits recalled for syringe quality defects

    Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2024·2024-08-21

    Merit Medical convenience kits with syringe quality issues recalled nationwide

    Merit Medical is recalling convenience kits containing syringes with quality issues including leaks and breakage that may pose a risk to patients receiving intravenous fluid administration.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2024·2024-08-21

    Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks

    Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2024·2024-08-21

    Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage

    Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2024·2024-08-21

    Merit Medical Convenience Kits with Recalled Syringes Pose Quality Risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac dia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage

    Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2024·2024-08-21

    Merit Medical convenience kits recalled for syringe leaks and breakage risks

    Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage. The recalled kits may pose a risk to patients undergoing vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2024·2024-08-21

    Merit Medical cardiac kits contain plastic syringes with quality defects

    Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2024·2024-08-21

    Merit Medical Syringes in Convenience Kits Recalled for Leaks and Breakage

    Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality defects that may pose a risk to patient health. Approximately 3,647 kits were distributed nationwide.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide