Merit Medical Systems, Inc.
Merit Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2026, with 144 FDA device recalls on record.
Top product codes for Merit Medical Systems, Inc.
FDA recalls by Merit Medical Systems, Inc.
10 most recent of 144- Z-2517-2026 — Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
- Z-2003-2026 — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Z-2002-2026 — Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
- Z-2004-2026 — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Z-1575-2026 — CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
- Z-1576-2026 — ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
- Z-1577-2026 — 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
- Z-1579-2026 — BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A
- Z-1578-2026 — DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A
- Z-1125-2026 — Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Merit Medical Systems, Inc.
1–100 of 180- K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set
- K262086 — PreludeSYNC Radial Compression Device
- K254073 — StatSeal Disc
- K251802 — STAR RF Ablation System
- K252892 — SCOUT MD Surgical Guidance System
- K250853 — Merit Syringe
- K251265 — Resilience Fully Covered Esophageal Stent System
- K250909 — Prelude Wave Hydrophilic Sheath Introducer
- K242229 — Micro Ace Gold Advanced Micro Access System
- K242873 — Ventrax Delivery System
- K241521 — Prelude Small O.D. Introducer Guide Wire
- K233268 — Impress Angiographic Catheter
- K240261 — Siege Vascular Plug (3 models)
- K233813 — Bearing nsPVA Express
- K230418 — Mighty Wire Guide Wire
- K232609 — Micro Ace Advanced Micro Access System
- K231246 — Ventrax Delivery System (VTR851)
- K212696 — Aspira Pleural Drainage System
- K223872 — Low Profile Companion Sheath
- K213845 — HeRO Graft
- K212882 — SCOUT BX Delivery System
- K213434 — Elation Pulmonary Balloon Dilation Catheter
- K212675 — Aspira Peritoneal Drainage System
- K212199 — ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
- K211405 — Prelude Guide Sheath
- K211525 — SwiftNINJA Steerable Microcatheter
- K203724 — HeRO Graft, HeRO Adapter
- K201674 — Cultura Collection and Transport System
- K202610 — Ventrax Delivery System
- K201595 — Merit Hydrophilic Guide Wire
- K201166 — Temno Elite Biopsy System
- K193082 — Fountain ValveTip Infusion Catheter
- K201907 — ClariVein IC
- K193507 — Merit ONE Snare System
- K192907 — Advocate PTA Catheter
- K191596 — Arcadia Balloon Catheter
- K191608 — Impress Angiographic Catheter
- K190175 — S-MAK XL
- K182216 — Merit Syringe
- K182279 — Merit Syringe
- K181200 — AEROmini Tracheobronchial Stent System
- K180723 — PreludeSYNC DISTAL Radial Compression System
- K173548 — Merit Pursue Microcatheter
- K180450 — Corvocet Biopsy System
- K173750 — Prelude IDeal Hydrophilic Sheath Introducer
- K173601 — Merit Syringe
- K173621 — Advocate PTA Catheter
- K172637 — HeRO Graft
- K172117 — Prelude Pursuit Splittable Sheath Introducer
- K171362 — Merit Syringe
- K172081 — Maestro Microcatheter
- K163597 — VacLok AT Vacuum Syringe
- K170532 — True Form Reshapable Guide Wire
- K170933 — Merit Hydrophilic Guide Wire
- K163084 — Merit Coronary Control Syringe
- K170700 — Inqwire Diagnostic Guide Wire
- K170668 — HeartSpan Steerable Sheath Introducer
- K163575 — Inqwire Diagnostic Guide Wire
- K162988 — PreludeSYNC Radial Compression Device
- K161921 — SwiftNINJA Microcatheter
- K162777 — Squirt Fluid Delivery System
- K161392 — Elation Pulmonary Balloon Dilation
- K160107 — DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
- K151967 — Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
- K153337 — Corvocet Biopsy System
- K153672 — basixTOUCH40 Inflation Syringe
- K152783 — Merit 20 mL Syringe
- K151925 — Elation Wireguided Balloon Dilation Catheter
- K152381 — Prelude SNAP Splittable Hydrophilic Sheath Introducer
- K152116 — 5.5 F Worley Advanced LVI Lateral Vein Introducer
- K151373 — Corvocet Coaxial Introducer
- K151497 — EN Snare Endovascular Snare System
- K150257 — PreludeEASE Hydrophilic Sheath Introducer
- K143255 — Prelude SNAP Splittable Sheath Introducer
- K143429 — Passage Hemostasis Valve
- K142051 — PRELUDE PLASTIC JACKETED GUIDE WIRE
- K141295 — MERIT HYDROPHILIC GUIDEWIRE
- K141408 — RESOLVE BILIARY LOCKING DRAINAGE CATHETER
- K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
- K142265 — ONE Snare Endovascular Microsnare System
- K142636 — Merit 10mL Syringe
- K140543 — PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
- K140608 — MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
- K140513 — MERIT SAFETY INTRODUCER NEEDLE
- K141363 — CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
- K140475 — ROTATING ADAPTERS
- K132720 — HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
- K133230 — INQWIRE DIAGNOSTIC GUIDE WIRE
- K132155 — Merit ASAPLP Aspiration Catheter
- K132164 — HEARTSPAN STEERABLE INTRODUCER KIT
- K132409 — CONCIERGE GUIDING CATHETER
- K131710 — MERIT HYDROPHILIC GUIDE WIRE
- K130566 — BASIXTOUCH
- K130259 — BEARING NSPVA EMBOLIZATION PARTICLES
- K130791 — PRELUDE SHEATH INTRODUCER
- K130588 — MERIT HYDROPHILIC GUIDE WIRE
- K123609 — MERIT HYDROPHILIC GUIDE WIRE
- K122088 — MERIT ONE SNARE SYSTEM
- K122089 — OSTIAL PRO STENT POSITIONING SYSTEM
- K120644 — MERIT HYDROPHILIC GUIDE WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.