Manufacturer
147 recalls in our database name Merit Medical Systems, Inc. as the manufacturing or recalling firm.
Of the 147 recalls from Merit Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (7%) are Severe.
Which agencies issued them
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Merit Medical is updating instructions for the EsophyX Z+ Fastener Delivery Device due to risks associated with device over-rotation and multiple fastener deployment.
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.
Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
Merit Medical Systems is recalling 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and infection.
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.
Merit Medical Systems is recalling 41,411 Monarch Inflation Devices because manufacturing defects caused holes in the sterile barrier.
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.
Merit Medical is recalling 3,631 catheter extractor convenience kits due to defective syringes with leaks and breakage. The identified quality issues may compromise patient safety during catheter removal.
Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage that may pose patient safety risks in cardiac and vascular procedures.
Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.
Merit Medical is recalling 1,390 convenience kits containing plastic syringes with identified quality issues including leaks and breakage. The kits, distributed nationwide, may pose a risk to patient health.