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Merit Medical Systems, Inc. FDA Recalls
97 recalls on file across devices, 5 of them Class I and 91 still open. Matched by name to MMSI.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 Class IIMay 8, 2026Due to unsealed portions of pouches. |
| Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYClass IIApr 2, 2026catheter may experience resistance when being advanced over |
| Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYClass IIApr 2, 2026catheter may experience resistance when being advanced over |
| Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYClass IIApr 2, 2026catheter may experience resistance when being advanced over |
| BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96Class IFeb 13, 202616F dual-valved splittable sheath introducer due to a design |
| CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31KClass IFeb 13, 202616F dual-valved splittable sheath introducer due to a design |
| 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/BClass IFeb 13, 202616F dual-valved splittable sheath introducer due to a design |
| ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, Class IFeb 13, 202616F dual-valved splittable sheath introducer due to a design |
| DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030Class IFeb 13, 202616F dual-valved splittable sheath introducer due to a design |
| Allwell Angioplasty Pack REF: IS-30-B1/BClass IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Allwell Inflation Device, for angiographic use REF: IS-30-AClass IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130Class IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261Class IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Merit Medical , Custom Manifold Kit REF: K09-13203AClass IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05Class IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922BClass IIDec 4, 2025Inflation device handle may detach from the syringe during p |
| PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, Class IIAug 4, 2025Hemostasis valve has a manufacturing defect and when used th |
| 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /Class IIJul 25, 2025Due to a manufacturing issue involving the silicone quad rin |
| Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334Class IIJun 5, 2025High pressure tubing may relax over time causing it to parti |
| Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825APClass IIJun 5, 2025High pressure tubing may relax over time causing it to parti |
| High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CClass IIJun 5, 2025High pressure tubing may relax over time causing it to parti |
| Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029Class IIJun 5, 2025High pressure tubing may relax over time causing it to parti |
| Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnlyClass IIMar 14, 2025Update to IFU to provide additional information related to |
| Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm CaClass IIMar 14, 2025Update to IFU to provide additional information related to |
| Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/DClass IIJan 27, 2025Hydrophilic Sheath Introducer labeled for 4F dilators may in |
| Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM MClass IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 InjecClass IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REFClass IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3Class IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 InjectoClass IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 InClass IIAug 30, 2024Due to a manufacturing process resulting in holes/breaches i |
| basixSKY Inflation Device, REF: SKY1802Class IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/BClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| StabiliT TOUCH Syringe, REF: IN8VCF/BClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| IntelliSystem Inflation Device, REF: IN1525/DClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| BlueFIRE Inflation Device, REF: IN10140Class IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/CClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/AClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/CClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| basixTOUCH Inflation Device, REF: IN8140/AClass IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410Class IIAug 19, 2024Inflation devices may have a small hole in the sterile barri |
| Custom Procedure Kit, REF: K12T-11077Class IIAug 12, 20247F sheath introducers labeled as 7.5F |
| Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)Class IIAug 12, 20247F sheath introducers labeled as 7.5F |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PreClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: CusClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: CustomClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: CusClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PreClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: RapClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PreClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: CusClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: OutClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12Class IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSClass IIJun 11, 2024Medical convenience kits contain plastic syringes affected b |
| Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S Class IIMay 22, 2024Due to older version of Instruction for Use (IFU) instructin |
| Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLYClass IIMar 14, 2024Their is a potential that sheaths labeled with .018 dilator |
| Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLYClass IIMar 14, 2024Their is a potential that sheaths labeled with .018 dilator |
| Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLYClass IINov 6, 2023The sterility of microcatheter and infusion system devices c |
| Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2Class IINov 6, 2023The sterility of microcatheter and infusion system devices c |
| Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEClass IINov 6, 2023The sterility of microcatheter and infusion system devices c |
| Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution onlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution onlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution onlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution onlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx OnlyClass IIApr 22, 2023There is a potential that valve assemblies will not open. pr |
| COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 UnitsClass IIMar 21, 2023Custom sheath Introducer contains incorrect needle size |
| Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/AClass IIFeb 15, 2023Product that was built for design verification testing was i |
| CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/Class IIAug 3, 2022Biopsy Systems have components that are misaligned due to an |
| CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCAClass IIAug 3, 2022Biopsy Systems have components that are misaligned due to an |
| AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102BClass IIMar 1, 2022A design change made to a hemostasis valve to improve manufa |
| Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410GClass IIMar 1, 2022A design change made to a hemostasis valve to improve manufa |
| MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm),Class IIJul 21, 2021There is a potential that a package sheath contains an incor |
| Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx OnlClass IIJun 30, 2021There is a potential that 7F sheaths are packaged as 10F she |
| Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, Class IIJun 30, 2021There is a potential that 7F sheaths are packaged as 10F she |
| basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or otheClass IIJun 10, 2021Due to a design issue, inflation syringe handle separating f |
| HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an innClass IIJan 19, 2021The labeled needle tip curvature of specific lots of transse |
| Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an innClass IIJan 19, 2021The labeled needle tip curvature of specific lots of transse |