Merit Medical Systems, Inc.: FDA recalls

FDA enforcement reports name Merit Medical Systems, Inc. as the recalling firm in 59 events. The events have 145 product records. The recalls started from 2006 to 2026.

See the 59 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

59 events, newest first.

FDA enforcement events of Merit Medical Systems, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
8 May 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…	Device	Class II	1	Ongoing
2 Apr 2026	Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY	Device	Class II	3	Ongoing
13 Feb 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,…	Device	Class I	5	Ongoing
4 Dec 2025	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…	Device	Class II	7	Ongoing
4 Aug 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.	Device	Class II	1	Ongoing
25 Jul 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.	Device	Class II	1	Ongoing
5 Jun 2025	High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C	Device	Class II	4	Ongoing
14 Mar 2025	Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly	Device	Class II	2	Ongoing
27 Jan 2025	Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D	Device	Class II	1	Ongoing
30 Aug 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…	Device	Class II	6	Ongoing
19 Aug 2024	Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C	Device	Class II	10	Ongoing
12 Aug 2024	Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)	Device	Class II	2	Ongoing
11 Jun 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,…	Device	Class II	23	Ongoing
22 May 2024	Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX…	Device	Class II	1	Ongoing
14 Mar 2024	Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY	Device	Class II	2	Ongoing
6 Nov 2023	Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D,…	Device	Class II	3	Ongoing
22 Apr 2023	Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only	Device	Class II	13	Ongoing
21 Mar 2023	COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units	Device	Class II	1	Ongoing
15 Feb 2023	Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A	Device	Class II	1	Ongoing
3 Aug 2022	CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A,…	Device	Class II	2	Ongoing
1 Mar 2022	Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A,…	Device	Class II	2	Ongoing
21 Jul 2021	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), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391	Device	Class II	1	Terminated
30 Jun 2021	Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.	Device	Class II	2	Terminated
10 Jun 2021	basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.	Device	Class II	1	Terminated
19 Jan 2021	HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle…	Device	Class II	2	Terminated
10 Nov 2020	Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation…	Device	Class II	3	Terminated
16 Sep 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	Device	Class II	3	Terminated
11 Mar 2020	PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT	Device	Class II	1	Terminated
13 Feb 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…	Device	Class II	2	Terminated
12 Sep 2019	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.	Device	Class II	1	Terminated
26 Oct 2018	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409	Device	Class II	2	Terminated
9 Jul 2018	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…	Device	Class II	1	Terminated
2 Feb 2018	1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.	Device	Class II	1	Terminated
20 Dec 2017	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…	Device	Class II	1	Terminated
14 Dec 2017	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	Device	Class II	1	Terminated
20 Sep 2017	Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B	Device	Class II	3	Terminated
23 Mar 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.	Device	Class II	1	Terminated
3 Mar 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…	Device	Class II	1	Terminated
16 Feb 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…	Device	Class I	1	Terminated
1 Dec 2016	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…	Device	Class II	1	Terminated
23 Sep 2016	Fluid Management Set. Catalog Number K08-MP5159A	Device	Class II	5	Terminated
25 Aug 2016	Merit Inflation Syringe Kit. Catalog Number KOS-02857	Device	Class II	1	Terminated
12 Aug 2016	Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patient’s vascular system.	Device	Class II	1	Terminated
15 Mar 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.	Device	Class II	1	Terminated
29 Jun 2015	ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.	Device	Class II	1	Terminated
4 Jun 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…	Device	Class II	1	Terminated
26 Sep 2014	Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.	Device	Class II	1	Terminated
14 Apr 2014	Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").	Device	Class II	2	Terminated
13 Mar 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.	Device	Class II	2	Terminated
18 Dec 2013	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…	Device	Class II	1	Terminated
6 Dec 2013	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…	Device	Class II	1	Terminated
30 Sep 2013	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.…	Device	Class I	1	Terminated
13 Sep 2013	Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.	Device	Class II	1	Terminated
2 May 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.	Device	Class II	1	Terminated
16 Jan 2013	Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.	Device	Class II	1	Terminated
21 Nov 2012	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…	Device	Class II	1	Terminated
14 Sep 2012	Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp; 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.	Device	Class II	1	Terminated
8 Jun 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.	Device	Class II	1	Terminated
24 Feb 2006	Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.	Drug	Class I	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Merit Medical Systems, Inc.: events for each product type
Type		Events
Device		58
Drug		1

Merit Medical Systems, Inc.: events in each class
Class		Events
Class II		55
Class I		4

Share of the events of the firm in Class I: 7%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 21

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Merit Medical Systems, Inc., by the year that the recall started. The largest year is 2013, with 6 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Merit Medical Systems, Inc.: FDA recalls. https://recallregister.com/firm/merit-medical-systems-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: UT, VA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Merit Medical Systems, Inc. have?: Class II: 55 events. Class I: 4 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Merit Medical Systems, Inc. have?: Device: 58 events. Drug: 1 event.
What is the newest FDA recall of Merit Medical Systems, Inc.?: FDA event 98818, which the firm started on 8 May 2026. The first product in the record is: 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…
How many FDA recalls of Merit Medical Systems, Inc. have the status Ongoing?: 21 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.