Merit Medical
14 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Merit Medical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-01FDA-DeviceClass IStop using Merit Medical BioFlo DuraMax Catheter
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.
- 2026-04-01FDA-DeviceClass IStop using Merit Medical DuraMax catheters
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.
- 2026-04-01FDA-DeviceClass IStop using Merit Medical 16F sheath introducer
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.
- 2026-04-01FDA-DeviceClass IStop using Merit Medical ProGuide dialysis catheters
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.
- 2026-04-01FDA-DeviceClass IStop using Merit Medical CentrosFLO catheters
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.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical angioplasty packs
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical Custom Procedure Kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical Custom Manifold Kit
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical inflation kits
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical vascular tray immediately
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using Merit Medical Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
- 2026-01-28FDA-DeviceClass IIStop using recalled Merit Medical inflation device
Inflation device handle may detach from the syringe during procedure.
- 2025-11-26FDA-DeviceClass IIPhD 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.
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.
- 2016-10-12FDA-DeviceClass IICheck Merit Inflation Syringe Kit labels
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
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