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 Nov 25, 2020

MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
FDA Devices Moderate Nov 25, 2020

Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
FDA Devices Moderate Nov 25, 2020

Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
FDA Devices Moderate May 27, 2020

DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Devices Moderate May 27, 2020

DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Devices Moderate May 20, 2020

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
FDA Devices Moderate May 6, 2020

PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
FDA Devices Moderate Apr 22, 2020

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
FDA Devices Moderate Oct 9, 2019

Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
FDA Devices Moderate Oct 9, 2019

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
FDA Devices Moderate Aug 22, 2018

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Devices Moderate Aug 22, 2018

Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However,
FDA Devices Moderate Mar 28, 2018

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
FDA Devices Moderate Mar 28, 2018

Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
FDA Devices Moderate Mar 28, 2018

Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
FDA Devices Moderate Feb 28, 2018

PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
FDA Devices Moderate May 3, 2017

1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
FDA Devices Moderate Apr 19, 2017

The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture
FDA Devices Critical Apr 5, 2017

7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequ
FDA Devices Moderate Jan 11, 2017

PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
FDA Devices Moderate Nov 30, 2016

Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
FDA Devices Moderate Nov 30, 2016

Manifold Kit. Catalog Number K09-11867AP
FDA Devices Moderate Nov 30, 2016

Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
FDA Devices Moderate Nov 30, 2016

Waste Management Kit. Catalog Number K10-04381AP
FDA Devices Moderate Nov 30, 2016

Fluid Management Set. Catalog Number K08-MP5159A
FDA Devices Moderate Nov 30, 2016

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Devices Moderate Oct 12, 2016

Merit Inflation Syringe Kit. Catalog Number KOS-02857
FDA Devices Moderate Apr 20, 2016

Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
FDA Devices Moderate Aug 19, 2015

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
FDA Devices Moderate Jul 1, 2015

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
FDA Devices Moderate Nov 12, 2014

Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
FDA Devices Moderate Apr 30, 2014

Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
FDA Devices Moderate Apr 30, 2014

Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
FDA Devices Moderate Apr 9, 2014

Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
FDA Devices Moderate Apr 9, 2014

Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
FDA Devices Critical Feb 26, 2014

Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the prod
FDA Devices Moderate Feb 5, 2014

Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead
FDA Devices Moderate Jan 8, 2014

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
FDA Devices Moderate Oct 30, 2013

Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
FDA Devices Moderate Jul 10, 2013

Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the p
FDA Devices Moderate Jun 5, 2013

Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
FDA Devices Moderate Feb 27, 2013

Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
FDA Devices Moderate Jan 16, 2013

Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
FDA Devices Moderate Dec 12, 2012

Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
FDA Drug Critical Nov 14, 2012

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

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