Merit Medical Systems, Inc
97 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate Jan 28, 2026
Allwell Inflation Device, for angiographic use REF: IS-30-A
FDA Devices Moderate Jan 28, 2026
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN41…
FDA Devices Moderate Jan 28, 2026
Merit Medical , Custom Manifold Kit REF: K09-13203A
FDA Devices Moderate Jan 28, 2026
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
FDA Devices Moderate Jan 28, 2026
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C…
FDA Devices Moderate Jan 28, 2026
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
FDA Devices Moderate Sep 17, 2025
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore…
FDA Devices Moderate Aug 20, 2025
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, …
FDA Devices Moderate Aug 20, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Devices Moderate Aug 20, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
FDA Devices Moderate Apr 30, 2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
FDA Devices Moderate Apr 30, 2025
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
FDA Devices Moderate Apr 2, 2025
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
FDA Devices Moderate Oct 23, 2024
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
FDA Devices Moderate Oct 23, 2024
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inf…
FDA Devices Moderate Oct 23, 2024
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K0…
FDA Devices Moderate Oct 23, 2024
basixSKY Inflation Device, REF: SKY1802
FDA Devices Moderate Oct 23, 2024
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syrin…
FDA Devices Moderate Oct 23, 2024
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
FDA Devices Moderate Oct 23, 2024
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
FDA Devices Moderate Oct 23, 2024
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…
FDA Devices Moderate Oct 23, 2024
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
FDA Devices Moderate Oct 23, 2024
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/S…
FDA Devices Moderate Oct 2, 2024
Custom Procedure Kit, REF: K12T-11077
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management …
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Cathete…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit)…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fl…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), …
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K0…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring …
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tr…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiogra…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: …
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suctio…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monit…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiograph…
FDA Devices Moderate Aug 21, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Managem…
FDA Devices Moderate Jul 3, 2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6…
FDA Devices Moderate May 29, 2024
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
FDA Devices Moderate May 29, 2024
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
FDA Devices Moderate Jan 10, 2024
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28…
FDA Devices Moderate Jan 10, 2024
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
FDA Devices Moderate Jun 21, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
FDA Devices Moderate Jun 21, 2023