The Recall Desk

Manufacturer

Merit Medical Systems, Inc.

94 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.

1–25 of 94

  • Severity pendingFDA (Devices)·Z-2517-2026·2026-06-24

    Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669

    Pending LLM rewrite. Source: FDA_DEVICE Z-2517-2026.

    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-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
  • 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
  • Severity pendingFDA (Devices)·Z-1575-2026·2026-04-01

    CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A,

    Pending LLM rewrite. Source: FDA_DEVICE Z-1575-2026.

    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
  • Severity pendingFDA (Devices)·Z-1578-2026·2026-04-01

    DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871

    Pending LLM rewrite. Source: FDA_DEVICE Z-1578-2026.

    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
  • Severity pendingFDA (Devices)·Z-1579-2026·2026-04-01

    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H

    Pending LLM rewrite. Source: FDA_DEVICE Z-1579-2026.

    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
  • Severity pendingFDA (Devices)·Z-1129-2026·2026-01-28

    Allwell Angioplasty Pack REF: IS-30-B1/B

    Pending LLM rewrite. Source: FDA_DEVICE Z-1129-2026.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1123-2026·2026-01-28

    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130

    Pending LLM rewrite. Source: FDA_DEVICE Z-1123-2026.

    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
  • Severity pendingFDA (Devices)·Z-1127-2026·2026-01-28

    Merit Medical , Custom Manifold Kit REF: K09-13203A

    Pending LLM rewrite. Source: FDA_DEVICE Z-1127-2026.

    Product
    Merit Medical , Custom Manifold Kit REF: K09-13203A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1126-2026·2026-01-28

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05

    Pending LLM rewrite. Source: FDA_DEVICE Z-1126-2026.

    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
  • Severity pendingFDA (Devices)·Z-2553-2025·2025-09-17

    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 0088445

    Pending LLM rewrite. Source: FDA_DEVICE Z-2553-2025.

    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
  • Severity pendingFDA (Devices)·Z-2294-2025·2025-08-20

    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

    Pending LLM rewrite. Source: FDA_DEVICE Z-2294-2025.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    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