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Merit Medical Systems, Inc Recalls

92 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Merit Medical Systems, Inc.

92Total Recalls
6Critical
11.9MUnits Affected
Apr 2, 2026Most Recent
All Recalls

Every Merit Medical Systems, Inc Recall

Sorted by most recent. Click any recall for full details.

92 recalls
High RiskFDA
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Medical Devices·0 affected·Apr 2, 2026
CriticalFDA
Merit Medical Systems, Inc.
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CEN...
Surgical Devices·35,591 affected·Feb 13, 2026
CriticalFDA
Merit Medical Systems, Inc.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Surgical Devices·131 affected·Feb 13, 2026
CriticalFDA
Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Medical Devices·368,264 affected·Feb 13, 2026
CriticalFDA
Merit Medical Systems, Inc.
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H96...
Surgical Devices·47,153 affected·Feb 13, 2026
High RiskFDA
Merit Medical Systems, Inc.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Medical Devices·173,645 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4...
Medical Devices·4,163,123 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Manifold Kit REF: K09-13203A
Medical Devices·2,192 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Medical Devices·864 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A...
Medical Devices·18,897 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 ...
Diagnostic Devices·447 affected·Jul 25, 2025
High RiskFDA
Merit Medical Systems, Inc.
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP,...
Medical Devices·6,327 affected·Jun 5, 2025
High RiskFDA
Merit Medical Systems, Inc.
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Medical Devices·2,779 affected·Jun 5, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Medical Devices·1,655 affected·Mar 14, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILE...
Medical Implants·7,453 affected·Mar 14, 2025
High RiskFDA
Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Medical Devices·40 affected·Jan 27, 2025
High RiskFDA
Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is...
Surgical Devices·432 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Inject...
Surgical Devices·51,900 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syr...
Surgical Devices·110,650 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Medical Devices·16,439 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K0...
Medical Devices·7,099 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Medical Devices·70 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Medical Devices·12,910 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Medical Devices·290 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Medical Devices·14,120 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
Medical Devices·24 affected·Aug 12, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste...
Medical Devices·2,388 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introd...
Cardiac Devices·55,305 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angi...
Cardiac Devices·103,369 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentes...
Cardiac Devices·72,115 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Man...
Cardiac Devices·188,837 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe ...
Surgical Devices·1,390 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure...
Cardiac Devices·69 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis ...
Diagnostic Devices·317,115 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure K...
Cardiac Devices·168,157 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe ...
Cardiac Devices·13,560 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit ...
Medical Devices·1,753,625 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter an...
Surgical Devices·7,442 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pr...
Cardiac Devices·34,197 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG...
Diagnostic Devices·52,410 affected·May 22, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·18 affected·Mar 14, 2024
High RiskFDA
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Medical Devices·27 affected·Mar 14, 2024
High RiskFDA
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC21...
Surgical Devices·717 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Surgical Devices·59 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Surgical Devices·1,054 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·17 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·40 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Surgical Devices·156 affected·Apr 22, 2023