Merit Medical Systems, Inc
Jordan, UT
This page shows every FDA and USDA recall linked to Merit Medical Systems, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
206
Total Recalls
2003
First Recall
2026
Most Recent
Merit Medical , Custom Procedure Kit
Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Jan 16, 2026
· Device
Open, Classified
Merit Medical , Custom Manifold Kit
REF: K09-13203A
Jan 16, 2026
· Device
Open, Classified
Merit Medical , Custom Waste Management Kit Vascular Tray
REF: K10T-05261
Jan 16, 2026
· Device
Open, Classified
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL
Reference Numbers: ENDO-AN2030/B IN4130/CNK IN413...
Jan 16, 2026
· Device
Open, Classified
Merit Medical , Custom Inflation Kit
REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-...
Jan 16, 2026
· Device
Open, Classified
Allwell Angioplasty Pack
REF: IS-30-B1/B
Jan 16, 2026
· Device
Open, Classified
Allwell Inflation Device, for angiographic use
REF: IS-30-A
Jan 16, 2026
· Device
Open, Classified
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05...
Nov 17, 2025
· Device
Open, Classified
10Fore Hemostasis Valve
Catalog Number / UDI-DI code:
MAPTEN4 / 00884450821305
MAPTEN42 / 00884450832509
MAPTE...
Sep 11, 2025
· Device
Open, Classified
Custom Manifold Kit:
REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B,...
Aug 12, 2025
· Device
Open, Classified
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Aug 12, 2025
· Device
Open, Classified
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Aug 12, 2025
· Device
Open, Classified
Custom Waste Management Kit:
REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Aug 12, 2025
· Device
Open, Classified
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2...
Apr 21, 2025
· Device
Open, Classified
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Apr 21, 2025
· Device
Open, Classified
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Mar 24, 2025
· Device
Open, Classified
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Oct 11, 2024
· Device
Open, Classified
Monarch Inflation Device 30 atm/bar REF IN2130
Injector And Syringe, Angiographic/Syringe, Balloon Inflation...
Oct 11, 2024
· Device
Open, Classified
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Oct 11, 2024
· Device
Open, Classified
Melrose Wakefield Hospital REF K05T-2159
Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The...
Oct 11, 2024
· Device
Open, Classified
BlueFIRE Inflation Device, REF: IN10140
Oct 11, 2024
· Device
Open, Classified
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN...
Oct 11, 2024
· Device
Open, Classified
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN233...
Oct 11, 2024
· Device
Open, Classified
StabiliT TOUCH Syringe, REF: IN8VCF/B
Oct 11, 2024
· Device
Open, Classified
IntelliSystem Inflation Device, REF: IN1525/D
Oct 11, 2024
· Device
Open, Classified
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Oct 11, 2024
· Device
Open, Classified
basixSKY Inflation Device, REF: SKY1802
Oct 11, 2024
· Device
Open, Classified
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C,...
Oct 11, 2024
· Device
Open, Classified
basixTOUCH Inflation Device, REF: IN8140/A
Oct 11, 2024
· Device
Open, Classified
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque...
Oct 11, 2024
· Device
Open, Classified
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430...
Oct 11, 2024
· Device
Open, Classified
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Oct 11, 2024
· Device
Open, Classified
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Sep 20, 2024
· Device
Open, Classified
Custom Procedure Kit, REF: K12T-11077
Sep 20, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syring...
Aug 12, 2024
· Device
Open, Classified