PlainRecalls

Merit Medical Systems, Inc.

Compiled from official public sources by the publisher.

145 recalls on record · Latest: Jun 24, 2026

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Agency notice ledger

Federal filing book Merit Medical Systems, Inc. HEAVY-BOOK · MULTI-AGENCY

#110 of 14,151 · 145 notices · 0.139% archive

  • BOOK 145 notices
  • RANK #110 of 14,151
  • SHARE 0.139% archive
  • AGENCY FDA Devices (144)
  • CAT medical devices
  • CATS 2 categories
  • LATEST Jun 24, 2026
  • PHOTO Baxter Healthcare Corp

Nearest notice-volume peer: Baxter Healthcare Corp (1 notice gap)

Merit Medical Systems, Inc. accounts for about 0.139% of the 104,423-notice archive on 145 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Merit Medical Systems, Inc.'s standing among 14,151 recalling firms

Merit Medical Systems, Inc. ranks 110th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Merit Medical Systems, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

145 110th of 14151 higher than 14,041 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Merit Medical Systems, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Merit Medical Systems, Inc. holds about 0.139% of archive notices alongside 145 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026

How the 145 notices break down

Same federal filing book as the hero total — split by issuing agency, no new counts.

FDA Devices Moderate Jun 24, 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:

FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Devices Critical Apr 1, 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
FDA Devices Critical Apr 1, 2026

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
FDA Devices Critical Apr 1, 2026

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
FDA Devices Critical Apr 1, 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
FDA Devices Critical Apr 1, 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
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 IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
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 K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
FDA Devices Moderate Jan 28, 2026

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
FDA Devices Moderate Jan 28, 2026

Allwell Angioplasty Pack REF: IS-30-B1/B
FDA Devices Moderate Nov 26, 2025

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
FDA Devices Moderate Sep 17, 2025

10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
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, K09-14000A, K09T-12020D, K09T-12275B
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 Aug 20, 2025

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
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 inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
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, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-0255
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 Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
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 to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
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/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Devices Moderate Oct 23, 2024

BlueFIRE Inflation Device, REF: IN10140
FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Devices Moderate Oct 23, 2024

basixTOUCH Inflation Device, REF: IN8140/A
FDA Devices Moderate Oct 23, 2024

StabiliT TOUCH Syringe, REF: IN8VCF/B
FDA Devices Moderate Oct 23, 2024

IntelliSystem Inflation Device, REF: IN1525/D
FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
FDA Devices Moderate Oct 2, 2024

Custom Procedure Kit, REF: K12T-11077
FDA Devices Moderate Oct 2, 2024

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
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 System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
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), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.
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), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09
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:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
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 Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.

Merit Medical Systems, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms that share this firm's dominant product category.

Baxter Healthcare Corp 144 Valorem Surgical LLC 144 Atrium Medical Corporation 150 Teleflex LLC 140

Frequently Asked Questions

How many federal recall notices name Merit Medical Systems, Inc.? ▼
PlainRecalls indexes 145 distinct federal recall events naming Merit Medical Systems, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Merit Medical Systems, Inc. sit among other recalling firms? ▼
Merit Medical Systems, Inc. ranks #110 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Merit Medical Systems, Inc.'s notices? ▼
FDA Devices accounts for 144 of this firm's 145 indexed notices across 2 issuing agencies.
What product category dominates Merit Medical Systems, Inc.'s filing book? ▼
Filings for Merit Medical Systems, Inc. span 2 product categories, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Merit Medical Systems, Inc.: 145 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Merit Medical Systems, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026