Merit Medical Systems recalls
Merit Medical Systems appears in 147 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance…
FDA Device · Class II · 2026-10-21 · Merit Medical Systems - Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA
FDA Device · Class II · 2026-10-07 · Merit Medical Systems - Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI co…
FDA Device · Class II · 2026-06-24 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H9651…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
FDA Device · Class I · 2026-04-01 · Merit Medical Systems - Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K0…
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130…
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Allwell Angioplasty Pack REF: IS-30-B1/B
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Merit Medical , Custom Manifold Kit REF: K09-13203A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - Allwell Inflation Device, for angiographic use REF: IS-30-A
FDA Device · Class II · 2026-01-28 · Merit Medical Systems - PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800…
FDA Device · Class II · 2025-11-26 · Merit Medical Systems - 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10F…
FDA Device · Class II · 2025-09-17 · Merit Medical Systems - Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K0…
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
FDA Device · Class II · 2025-08-20 · Merit Medical Systems - Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO…
FDA Device · Class II · 2025-04-30 · Merit Medical Systems - Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
FDA Device · Class II · 2025-04-30 · Merit Medical Systems - Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
FDA Device · Class II · 2025-04-02 · Merit Medical Systems - basixTOUCH Inflation Device, REF: IN8140/A
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, An…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angio…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - BlueFIRE Inflation Device, REF: IN10140
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - IntelliSystem Inflation Device, REF: IN1525/D
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiogr…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - StabiliT TOUCH Syringe, REF: IN8VCF/B
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - basixSKY Inflation Device, REF: SKY1802
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe i…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector An…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Custom Procedure Kit, REF: K12T-11077
FDA Device · Class II · 2024-10-02 · Merit Medical Systems - Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
FDA Device · Class II · 2024-10-02 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tr…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley adv…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introdu…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiograp…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit),…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems