Merit Medical
6 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.
- 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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