Merit Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 140 total recalls

Merit Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (140)

FDA medical device enforcement actions by Merit Medical Systems, Inc.. Showing most recent 50.

Date Product Reason Class
Feb 13, 2026 DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A,... 16F dual-valved splittable sheath introducer due to a design defect, may not ... Class I
Feb 13, 2026 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021... 16F dual-valved splittable sheath introducer due to a design defect, may not ... Class I
Feb 13, 2026 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-17... 16F dual-valved splittable sheath introducer due to a design defect, may not ... Class I
Feb 13, 2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452... 16F dual-valved splittable sheath introducer due to a design defect, may not ... Class I
Feb 13, 2026 CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, C... 16F dual-valved splittable sheath introducer due to a design defect, may not ... Class I
Dec 4, 2025 Allwell Angioplasty Pack REF: IS-30-B1/B Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07... Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K... Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Merit Medical , Custom Manifold Kit REF: K09-13203A Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Number... Inflation device handle may detach from the syringe during procedure. Class II
Dec 4, 2025 Allwell Inflation Device, for angiographic use REF: IS-30-A Inflation device handle may detach from the syringe during procedure. Class II
Aug 4, 2025 PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, ... Hemostasis valve has a manufacturing defect and when used the valve cap may r... Class II
Jul 25, 2025 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821... Due to a manufacturing issue involving the silicone quad ring where the ring ... Class II
Jun 5, 2025 Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05... High pressure tubing may relax over time causing it to partially separate fro... Class II
Jun 5, 2025 High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C High pressure tubing may relax over time causing it to partially separate fro... Class II
Jun 5, 2025 Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 High pressure tubing may relax over time causing it to partially separate fro... Class II
Jun 5, 2025 Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K... High pressure tubing may relax over time causing it to partially separate fro... Class II
Mar 14, 2025 Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners,... Update to IFU to provide additional information related to risk with device ... Class II
Mar 14, 2025 Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, Sterile... Update to IFU to provide additional information related to risk with device ... Class II
Jan 27, 2025 Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly... Class II
Aug 30, 2024 Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal I... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Inser... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Inserti... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 30, 2024 Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angi... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 30, 2024 Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis V... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 30, 2024 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographi... Due to a manufacturing process resulting in holes/breaches in the Tyvek steri... Class II
Aug 19, 2024 IntelliSystem Inflation Device, REF: IN1525/D Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 StabiliT TOUCH Syringe, REF: IN8VCF/B Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8140/A Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 BlueFIRE Inflation Device, REF: IN10140 Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 basixSKY Inflation Device, REF: SKY1802 Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 19, 2024 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... Inflation devices may have a small hole in the sterile barrier of the device ... Class II
Aug 12, 2024 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 7F sheath introducers labeled as 7.5F Class II
Aug 12, 2024 Custom Procedure Kit, REF: K12T-11077 7F sheath introducers labeled as 7.5F Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety ... Class II

View all 140 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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