Every recall we track for Merit Medical Systems, Inc — 117 in all — plus the complaints and injury reports the public filed about them.
Merit Medical recalls Splashwire Hydrophilic Guide Wire with unsealed pouches that may cause contamination during medical procedures. Affected units have specific UDI-DI codes and lot numbers. Consumers should contact Merit for details.
Philips recalls Bridge Prep Kit REF K12-09098C due to potential catheter resistance during guidewire advancement. Affected units have specific lot numbers and are sterile for medical use only.
Philips recalls Bridge Prep Kit REF K12-09098B (Sterile EO, Rx ONLY) due to potential catheter resistance during guidewire advancement. Affected units have specific lot numbers.
Philips recalls Bridge Prep Kit REF K12-09098C (Sterile EO, Rx ONLY) due to catheter resistance during guidewire advancement. Affected units have specific lot numbers.
Merit Medical recalls certain DuraMax Chronic Hemodialysis Catheters due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units have specific serial numbers.
Merit Medical recalls BioFlo DuraMax Catheters with specific serial numbers due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units include models H965103028011/A through H965103038181/A.
Merit Medical recalls 16F Dual Valved Splittable Sheath Introducers (non-sterile) due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units have specific reference numbers.
Merit Medical recalls ProGuide Chronic Dialysis Catheters with design defect that may cause bleeding, blockage, or procedure delays. Affected models include DC01455550/C and others. Contact for remedy.
Merit Medical Systems recalls CentrosFLO Hemodialysis Catheters with design defect that may not split properly, leading to bleeding, foreign bodies, or procedure delays. Affected models include CENFP15K/A through CENFT31K/D.
Merit Medical recalls Allwell Angioplasty Packs with REF: IS-30-B1/B due to risk of handle detaching during procedures. Affected units include specific lot numbers. Consumers should contact Merit Medical for details.
Merit Medical recalls custom procedure kits with reference numbers K12T-04270A, K12T-07956, and K12T-10922B due to risk of handle detaching during procedures.
Merit Medical recalls Custom Inflation Kit models K05-00761F to K05T-03201 due to risk of handle detaching during medical procedures.
Merit Medical recalls Custom Waste Management Kit Vascular Tray REF K10T-052: Inflation handle may detach during procedures, causing potential injury. Affected units have specific UDI and lot numbers.
Merit Medical recalls Custom Manifold Kit REF K09-132: Handle may detach during procedures. Affected units have specific UDI and lot numbers. Stop using immediately to prevent injury.
Merit Medical Systems, Inc
Merit Medical recalls Allwell Inflation Devices (REF: IS-30-A) for angiographic use due to risk of handle detaching during procedures. Affected units have specific UDI and lot numbers listed in the recall.
Merit Medical recalls PhD Hemostasis Valves with specific model numbers due to a manufacturing defect that may cause leakage, leading to procedure inconvenience or hemorrhage.
Merit Medical recalls 10Fore Hemostasis Valves with deformed silicone rings that may cause foreign bodies in fluid pathways. Affected units have specific catalog numbers and lot numbers.
Merit Medical recalls Custom Waste Management Kits with specific model numbers due to high pressure tubing that may relax over time, potentially trapping air in the patient's line. Affected units include K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, and K10-05825AP.
Merit Medical recalls high pressure tubing (HP9720E/C, HP9721E/C) due to risk of air trapping in patient lines. Affected units have specific serial numbers and expiration dates.
Merit Medical recalls custom tubing kits with serial numbers K04-00417, K04-00963, K04-01029 due to potential air trapping in medical lines that could affect patient safety.
Merit Medical recalls Custom Manifold Kits with specific model numbers due to high pressure tubing that may relax over time, potentially trapping air in the patient's line.
Merit Medical recalls EsophyX Z+ with SerosaFuse Implantable Fasteners due to potential over-rotation and multiple deployment risks. Affected units include specific fastener delivery devices and cartridges.
Merit Medical recalls EsophyX Z+ fastener delivery devices due to potential over-rotation and multiple fastener deployment risks. Affected units have specific lot numbers and require attention to prevent complications.
Merit Medical recalls Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque Device due to holes in the Tyvek sterile barrier that could compromise infection control during medical procedures.
Merit Medical recalls 30 ATM Monarch syringes with Tyvek barrier holes that could allow infection during procedures. Affected units have specific lot numbers. Consumers should contact Merit for details.
Merit Medical recalls 30 atm/bar Monarch Inflation Device with Tyvek barrier holes that could allow infection during medical procedures. Affected units have specific lot numbers and were sold in the U.S. from 2022 to 2023.
Merit Medical recalls Monarch Inflation Device 30 atm/bar REF IN2130 with holes in sterile Tyvek barrier that could cause infection during procedures.
Merit Medical recalls Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device due to holes in the Tyvek sterile barrier that could allow infection during medical procedures.
Merit Medical recalls Melrose Wakefield Hospital 30 ATM angiographic injectors due to Tyvek barrier holes that could allow contamination. Affected units have specific lot numbers and were sold between 2021-2023.
Merit Medical recalls IntelliSystem Inflation Device REF IN1525/D due to potential small hole in sterile barrier causing infection risk. Affected units have specific lot numbers and expiration dates.
Merit Medical recalls StabiliT TOUCH syringes with possible sterile barrier holes that could cause infections. Affected units have specific reference numbers and expiration dates.
Merit Medical recalls basixTOUCH Inflation Devices with potential small hole in sterile barrier that could expose users to pathogens, leading to infection. Affected units have specific lot numbers and expiration dates.
Merit Medical recalls BlueFIRE Inflation Device REF IN10140 due to potential small hole in sterile barrier causing infection risk. Affected units sold with specific lot number and expiration date.
Merit Medical recalls Blue Diamond Digital Inflation Devices with possible small holes in sterile barriers that could expose users to pathogens, leading to infection. Affected models include IN7152/C through IN7130/C with specific serial numbers and expiration dates.
Merit Medical recalls DiamondTOUCH Digital Inflation Devices with potential small holes in sterile barriers, risking infection from pathogens. Affected units have specific serial numbers and expiration dates.
Merit Medical recalls MONARCH Inflation Devices with specific model numbers and batch codes due to potential small holes in sterile barriers that could cause infection. Affected units may need replacement.
Merit Medical recalls basixSKY Inflation Device REF SKY1802 due to potential small hole in sterile barrier causing infection risk. Affected units have specific lot numbers and expiration dates.
Merit Medical recalls Custom Inflation Kits with serial numbers K05-00052M to K05-03150. Affected kits may have a small hole in the sterile barrier, risking pathogen exposure and infection.
Merit Medical recalls basixTOUCH Inflation Devices with possible small holes in sterile barriers that could expose users to pathogens, leading to infection. Affected units have specific model and lot numbers.
Merit Medical recalls Prelude Sheath Introducer 7.5F models with incorrect 7F labeling that could lead to improper use in medical procedures.
Merit Medical recalls Custom Procedure Kit REF K12T-11077 with 7F sheath introducers labeled as 7.5F. This mismatch may cause improper use during medical procedures.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, risking patient health. Affected kits include specific models and lot numbers.
Merit Medical recalls convenience kits with Jiangsu Shenli Medical syringes due to leaks and breakage risks. Affected kits may pose patient health hazards.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, posing health risks. Affected kits include specific model numbers and lot codes.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical Production Co. Ltd. that may leak or break, posing health risks. Affected kits include specific models and lot numbers.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, risking patient health. Affected kits include SafeSheath CSG/Worley advanced CSG models with specific catalog numbers.
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes K02 models due to leaks and breakage risks that could harm patients.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, risking patient health. Affected kits include Prelude Prestige (Introducer Catheter) models PLP-2505/A, PLP-2514/A, and PLP-2516/A.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, posing health risks. Affected kits include specific catalog numbers and lot numbers.
Recalled Merit Medical convenience kits containing Jiangsu Shenli Medical syringes may leak or break, posing health risks. Affected kits include specific models with catalog numbers listed.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, posing health risks. Affected kits include specific model numbers and lot codes listed in the recall notice.
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes that may leak or break, posing health risks. Affected kits include specific model numbers and lot codes listed in the recall.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical that may leak or break, posing health risks. Affected kits include ReSolve Thoracostomy Tray models with specific lot numbers.
T2260092
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes K04 models that may leak or break, risking patient health. Affected kits include specific catalog numbers and lot numbers.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical Production Co. Ltd. that may leak or break, posing health risks. Check your product model numbers to see if affected.
Merit Medical recalls convenience kits containing syringes from Jiangsu Shenli Medical Production Co. Ltd. that may leak or break, risking patient health. Affected kits include Safety Paracentesis Procedure Trays with specific model numbers.
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes K11-00382C due to leaks and breakage risks that could harm patients during medical procedures.
