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.

1–25 of 145

  • HighFDA (Devices)·Z-2517-2026·2026-06-24

    Splashwire hydrophilic guide wire pouches have unsealed portions

    Merit Medical Splashwire Hydrophilic Guide Wires are being recalled because of unsealed portions of pouches. 5,004 units are affected.

    Product
    Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 008844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2002-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.

    Product
    Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2004-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1575-2026·2026-04-01

    CentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1579-2026·2026-04-01

    BioFlo DuraMax catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1576-2026·2026-04-01

    ProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling ProGuide Chronic Dialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1578-2026·2026-04-01

    DuraMax hemodialysis catheter sheath introducer may not split as intended

    Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1577-2026·2026-04-01

    Merit 16F splittable sheath introducer recalled as Class I bulk product

    Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.

    Product
    16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2026·2026-01-28

    Custom inflation kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2026·2026-01-28

    basixCOMPAK inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2026·2026-01-28

    Custom procedure kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2026·2026-01-28

    Angioplasty packs recalled over inflation handles that may detach

    Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2026·2026-01-28

    Angiographic inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Inflation Device, for angiographic use REF: IS-30-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Waste management vascular trays recalled over inflation handles that may detach

    Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2026·2025-11-26

    Hemostasis valves recalled because the valve cap may remain depressed

    Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.

    Product
    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2553-2025·2025-09-17

    Hemostasis valves recalled because deformed quad rings may shed foreign bodies

    10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.

    Product
    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2025·2025-08-20

    Custom waste management kit tubing may trap air in the line

    Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.

    Product
    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2025·2025-08-20

    High pressure tubing may separate and trap air in the line

    High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.

    Product
    High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2025·2025-08-20

    Custom tubing kits recalled because high pressure tubing may trap air

    Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2025·2025-08-20

    Custom manifold kit tubing may separate and trap air in line

    Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

    Product
    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1640-2025·2025-04-30

    Merit Medical EsophyX Z+ Fastener Delivery Device Safety Update

    Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to risks associated with device over-rotation and multiple fastener deployment.

    Product
    Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1641-2025·2025-04-30

    Merit Medical EsophyX Z+ Fastener Delivery Device Instructions Update

    Merit Medical has updated instructions for the EsophyX Z+ fastener delivery device to provide additional information about risks associated with device over-rotation and multiple fastener deployment.

    Product
    Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1434-2025·2025-04-02

    Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators

    Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.

    Product
    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
    Category
    Medical Device
    Distribution
    0 states