Medical DeviceJun 24, 2026
Merit Medical Systems Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes recall — FDA Z-2517-2026
Due to unsealed portions of pouches.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Recall history in this database
Classification mix: Class II: 101, Class I: 5.
Medical DeviceApr 1, 2026
Merit Medical Systems CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B recall — FDA Z-1575-2026
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C recall — FDA Z-1576-2026
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF recall — FDA Z-1577-2026
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A recall — FDA Z-1579-2026
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 1, 2026
Merit Medical Systems DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A recall — FDA Z-1578-2026
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis,…
Class IFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical Systems Allwell Inflation Device, for angiographic use REF: IS-30-A recall — FDA Z-1124-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B recall — FDA Z-1123-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical , Custom Manifold Kit REF: K09-13203A recall — FDA Z-1127-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 recall — FDA Z-1125-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C recall — FDA Z-1126-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B recall — FDA Z-1128-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJan 28, 2026
Merit Medical Systems Allwell Angioplasty Pack REF: IS-30-B1/B recall — FDA Z-1129-2026
Inflation device handle may detach from the syringe during procedure.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceNov 26, 2025
Merit Medical Systems PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C recall — FDA Z-0533-2026
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceSep 17, 2025
Merit Medical Systems 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / recall — FDA Z-2553-2025
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Merit Medical Systems Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B recall — FDA Z-2295-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Merit Medical Systems Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 recall — FDA Z-2294-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Merit Medical Systems High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C recall — FDA Z-2293-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Merit Medical Systems Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q recall — FDA Z-2296-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 30, 2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly recall — FDA Z-1640-2025
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceApr 30, 2025
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener recall — FDA Z-1641-2025
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceOct 23, 2024
Merit Medical Systems basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C recall — FDA Z-0072-2025
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceOct 23, 2024
Merit Medical Systems Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe recall — FDA Z-0062-2025
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceOct 23, 2024
Merit Medical Systems Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G recall — FDA Z-0070-2025
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Merit Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.