Manufacturer
93 recalls in our database name Merit Medical Systems, Inc. as the manufacturing or recalling firm.
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 Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.
Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.
Merit Medical Systems is recalling the BioFlo DuraMax Catheter due to a design defect that prevents proper splitting, which may result in hemorrhage, thrombosis, and other serious complications.
CentrosFLO Hemodialysis Catheters are recalled due to a design defect that may prevent proper splitting of the sheath, risking hemorrhage, blood clots, and other serious complications.
Merit Medical Systems is recalling ProGuide Chronic Dialysis Catheters due to a design defect in the sheath introducer that may not split properly. This could lead to hemorrhage, blood clots, or loss of vascular access.
Merit Medical Systems is recalling the DuraMax Chronic Hemodialysis Catheter due to a design defect that prevents proper splitting, potentially causing hemorrhage, blood clots, device malfunction, and complications during dialysis treatment.
Merit Medical's 16F sheath introducers may fail to split properly, posing risks of hemorrhage, foreign body retention, and blood clots during vascular procedures. Approximately 368,264 units distributed worldwide are affected.
Merit Medical Custom Waste Management Kit Vascular Tray inflation device handles may detach from syringes during medical procedures. This Class II recall affects 864 units distributed worldwide.
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device (Model IS-30-A) due to risk that the handle may detach from the syringe during angiographic procedures.
Merit Medical custom procedure kits contain inflation devices whose handles may detach from the syringe during medical procedures, potentially compromising procedure execution.
Merit Medical is recalling Custom Manifold Kits (REF: K09-13203A) due to a hazard where the inflation device handle may detach from the syringe during procedures. Approximately 2,192 units were distributed worldwide.
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during procedure.
Merit Medical is recalling 18,897 Custom Inflation Kits because the inflation device handle may detach from the syringe during use, potentially affecting device function.
Merit Medical Systems is recalling inflation device units because the handle may detach from the syringe during medical procedures. Affected units: 4,163,123 worldwide.
Merit Medical Systems is recalling PhD Hemostasis Valves due to a manufacturing defect where the valve cap may remain depressed, causing potential leakage that could lead to hemorrhage during medical procedures.
Merit Medical is recalling 10Fore Hemostasis Valves due to a manufacturing defect where the silicone quad ring may be deformed or damaged, posing a risk of foreign body in the fluid pathway.
Merit Medical Systems is recalling 6,327 Custom Manifold Kits nationwide due to high-pressure tubing that may relax and separate from connectors, potentially trapping air that could enter the patient.
Merit Medical Systems is recalling high pressure tubing that may relax over time, partially separate from connectors, and trap air that could enter patients. The recall affects 8,040 units distributed nationwide.
A medical waste management kit with high-pressure tubing may relax and partially separate from the connector, potentially allowing air to enter a patient's system. Merit Medical Systems is recalling 858 units distributed nationwide.
Merit Medical's custom tubing kits may relax and separate from connectors, trapping air that could enter the patient. FDA recall affects 2,779 units distributed nationwide.
Merit Medical is updating instructions for the EsophyX Z+ fastener delivery device to address identified risks of device over-rotation and improper fastener deployment. No injuries have been reported.
The FDA has issued a Class II recall of Merit Medical's EsophyX Z+ with SerosaFuse Implantable Fasteners due to identified risks of device over-rotation and unintended multiple fastener deployment. The manufacturer is updating instructions for use to provide additional guidance on these risks.
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 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and infection.