Merit Medical Systems, Inc. recalls

42 recalls on record · latest: April 2, 2026

Official U.S. recall history for Merit Medical Systems, Inc., compiled from official government records.

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Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

April 2, 2026 · Medical device recalls Moderate risk catheter may experience resistance when being advanced over the guidewire

Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

April 2, 2026 · Medical device recalls Moderate risk catheter may experience resistance when being advanced over the guidewire

Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

April 2, 2026 · Medical device recalls Moderate risk catheter may experience resistance when being advanced over the guidewire

Merit Medical Systems, Inc. recalls DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103…

February 13, 2026 · Medical device recalls High risk 16F dual-valved splittable sheath introducer due to a design defect, may not sp…

Merit Medical Systems, Inc. recalls BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H9…

February 13, 2026 · Medical device recalls High risk 16F dual-valved splittable sheath introducer due to a design defect, may not sp…

16F Dual Valved Splittable Sheath Introducer recalled over sterility concerns

February 13, 2026 · Medical device recalls High risk 16F dual-valved splittable sheath introducer due to a design defect, may not sp…

Merit Medical Systems, Inc. recalls ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,…

February 13, 2026 · Medical device recalls High risk 16F dual-valved splittable sheath introducer due to a design defect, may not sp…

Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31…

February 13, 2026 · Medical device recalls High risk 16F dual-valved splittable sheath introducer due to a design defect, may not sp…

Merit Medical Systems, Inc. recalls Allwell Angioplasty Pack REF: IS-30-B1/B

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

Merit Medical Systems, Inc. recalls Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

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…

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

Merit Medical Systems, Inc. recalls Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

Merit Medical Systems, Inc. recalls Merit Medical , Custom Manifold Kit REF: K09-13203A

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

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…

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A

December 4, 2025 · Medical device recalls Moderate risk Inflation device handle may detach from the syringe during procedure.

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,…

August 4, 2025 · Medical device recalls Moderate risk Hemostasis valve has a manufacturing defect and when used the valve cap may rem…

Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00…

July 25, 2025 · Medical device recalls Moderate risk Due to a manufacturing issue involving the silicone quad ring where the ring is…

Merit Medical Systems, Inc. recalls Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

June 5, 2025 · Medical device recalls Moderate risk High pressure tubing may relax over time causing it to partially separate from…

Merit Medical Systems, Inc. recalls High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

June 5, 2025 · Medical device recalls Moderate risk High pressure tubing may relax over time causing it to partially separate from…

Merit Medical Systems, Inc. recalls Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

June 5, 2025 · Medical device recalls Moderate risk High pressure tubing may relax over time causing it to partially separate from…

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…

June 5, 2025 · Medical device recalls Moderate risk High pressure tubing may relax over time causing it to partially separate from…

Merit Medical Systems, Inc. recalls Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm C…

March 14, 2025 · Medical device recalls Moderate risk Update to IFU to provide additional information related to risk with device ove…

Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

March 14, 2025 · Medical device recalls Moderate risk Update to IFU to provide additional information related to risk with device ove…

Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

January 27, 2025 · Medical device recalls Moderate risk Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly c…

Merit Medical Systems, Inc. recalls Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Inje…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…

Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injecto…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…

Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…

Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 A…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…

Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device RE…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…

Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Mon…

August 30, 2024 · Medical device recalls Moderate risk Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile…