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.

76–93 of 93

  • HighFDA (Devices)·Z-1920-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

    Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve

    Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction

    Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

    Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction

    Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

    Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2023·2023-06-21

    FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure

    Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2023·2023-05-17

    Sheath Introducer Kit with Incorrect Needle Size Recalled

    Merit Medical Systems is recalling COBRA-OS Sheath Introducer Kits due to an incorrect needle size that may affect proper insertion during medical procedures.

    Product
    COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1352-2023·2023-04-19

    Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients

    Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.

    Product
    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2023·2022-11-02

    CorVocet Biopsy System recall due to potential unintended needle ejection

    Merit Medical Systems is recalling 2,894 CorVocet Biopsy Systems because misaligned components may cause the needle to eject unexpectedly when triggered outside the body, risking needle stick injuries.

    Product
    CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0137-2023·2022-11-02

    CorVocet Biopsy System recalled for needle ejection risk from component misalignment

    Merit Medical Systems is recalling CorVocet Biopsy Systems due to manufacturing defects that may cause the needle to eject when triggered outside the body, risking needle stick injuries to users or patients.

    Product
    CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0904-2022·2022-04-20

    AccessPLUS hemostasis valves recalled for internal guidewire entrapment risk

    Merit Medical is recalling AccessPLUS Large Bore Hemostasis Valves due to an internal design gap that can trap guidewires, potentially delaying medical procedures.

    Product
    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0903-2022·2022-04-20

    Access-9 Hemostasis Valves Recalled for Guidewire Entrapment Risk

    Merit Medical Systems is recalling 36,445 Access-9 Large Bore Hemostasis Valves due to an internal gap that can trap the guidewire, potentially delaying medical procedures.

    Product
    Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F,
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2239-2021·2021-08-18

    Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling

    Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2238-2021·2021-08-18

    Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size

    Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2243-2021·2021-08-18

    Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator

    Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.

    Product
    MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2021·2021-08-04

    Medical inflation device recalled due to handle separation risk

    Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.

    Product
    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Category
    Medical Device
    Distribution
    Distributed nationwide