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Merit Medical Systems Recalls
145 recalls on record · November 14, 2012 to June 24, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls BlueFIRE Inflation Device, REF: IN10140
Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls IntelliSystem Inflation Device, REF: IN1525/D
Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8140/A
Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Hazard: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injec
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 23, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3
Hazard: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
October 2, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
Hazard: 7F sheath introducers labeled as 7.5F
October 2, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Hazard: 7F sheath introducers labeled as 7.5F
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.