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Merit Medical Systems Recalls
145 recalls on record · November 14, 2012 to June 24, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690
Hazard: Due to unsealed portions of pouches.
May 6, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Hazard: catheter may experience resistance when being advanced over the guidewire
May 6, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Hazard: catheter may experience resistance when being advanced over the guidewire
May 6, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Hazard: catheter may experience resistance when being advanced over the guidewire
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96
Hazard: 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, impaired catheter function, loss of vessel for future vascular access.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030
Hazard: 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, impaired catheter function, loss of vessel for future vascular access.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Hazard: 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, impaired catheter function, loss of vessel for future vascular access.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,
Hazard: 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, impaired catheter function, loss of vessel for future vascular access.
April 1, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K
Hazard: 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, impaired catheter function, loss of vessel for future vascular access.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Allwell Angioplasty Pack REF: IS-30-B1/B
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Manifold Kit REF: K09-13203A
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A
Hazard: Inflation device handle may detach from the syringe during procedure.
January 28, 2026Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130
Hazard: Inflation device handle may detach from the syringe during procedure.
November 26, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,
Hazard: 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.
September 17, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /
Hazard: 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.
August 20, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Hazard: 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 trapped air being introduced into the patient.
August 20, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334
Hazard: 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 trapped air being introduced into the patient.
August 20, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Hazard: 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 trapped air being introduced into the patient.
August 20, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Hazard: 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 trapped air being introduced into the patient.
April 30, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca
Hazard: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
April 30, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Hazard: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
April 2, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hazard: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls StabiliT TOUCH Syringe, REF: IN8VCF/B
Hazard: 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.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Hazard: 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.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls basixSKY Inflation Device, REF: SKY1802
Hazard: 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.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410
Hazard: 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.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Hazard: 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.