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.

101–125 of 145

  • HighFDA (Devices)·Z-0456-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall

    Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2021·2020-11-25

    MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk

    Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.

    Product
    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2021·2020-11-25

    Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk

    Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.

    Product
    Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2020·2020-05-27

    Merit Medical Recalls DFINE Vertebral Assemblies Due to Incorrect Expiration Dates

    Merit Medical Systems is recalling 63 DFINE Vertebral Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2020·2020-05-27

    DFINE Vertebral Hydraulic Assemblies Recalled for Incorrect Expiration Dates

    Merit Medical Systems is recalling 228 DFINE Vertebral Hydraulic Assemblies because the labels display a five-year expiration date instead of the correct two-year shelf life.

    Product
    DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2020·2020-05-20

    Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error

    Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.

    Product
    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1702-2020·2020-04-22

    Merit Medical Recalls Nonsterile ChloraPrep Applicators for Vein Trays

    Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2020·2019-10-09

    Merit Medical Systems Recalls Vein Kits Due to Incorrect Latex Labeling

    Merit Medical Systems is recalling 24 Vein Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0026-2020·2019-10-09

    Merit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error

    Merit Medical Systems is recalling 88 Custom Procedure Kits because they were incorrectly labeled as latex-free.

    Product
    Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2823-2018·2018-08-22

    Merit Medical Recalls Pediatric Peritoneal Dialysis Catheters Due to Mix-Up

    Merit Medical Systems is recalling specific lots of Flex-Neck Classic Peritoneal Dialysis Catheters (Pediatric) due to a mix-up with adult catheters.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2018·2018-08-22

    Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

    Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

    Product
    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2018·2018-03-28

    Merit Medical Recalls Misconfigured Peritoneal Dialysis Catheters

    Merit Medical Systems is recalling 30 Flex-Neck Classic Peritoneal Dialysis Catheters because 2-cuff devices were incorrectly configured and labeled as 1-cuff products.

    Product
    Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1144-2018·2018-03-28

    Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration

    Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.

    Product
    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1145-2018·2018-03-28

    Merit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits

    Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.

    Product
    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0688-2018·2018-02-28

    Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers

    Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

    Product
    PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1889-2017·2017-05-03

    Merit Medical Recalls 1 mL Medallion Syringes Due to Plunger Tip Defect

    Merit Medical Systems is voluntarily recalling 1 mL Medallion Syringes because of a defect in the syringe plunger tip.

    Product
    1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1766-2017·2017-04-19

    Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Valve Seal Defect

    Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.

    Product
    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2017·2017-04-05

    Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk

    Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.

    Product
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2017·2017-01-11

    Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall

    Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.

    Product
    PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2017·2016-11-30

    Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

    Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

    Product
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.

    Product
    Waste Management Kit. Catalog Number K10-04381AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2017·2016-11-30

    Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier

    Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.

    Product
    Manifold Kit. Catalog Number K09-11867AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is recalling 53 Procedure Kits due to a compromised sterile barrier. The kits were distributed nationwide to specific states and Japan.

    Product
    Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
    Category
    Medical Device
    Distribution
    Distributed nationwide