Merit Medical Systems, Inc
97 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
FDA Devices Moderate Jun 21, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
FDA Devices Moderate Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
FDA Devices Moderate Jun 21, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
FDA Devices Moderate May 17, 2023
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
FDA Devices Moderate Apr 19, 2023
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
FDA Devices Moderate Nov 2, 2022
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, C…
FDA Devices Moderate Aug 18, 2021
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For t…
FDA Devices Moderate Aug 18, 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 O…
FDA Devices Moderate Aug 4, 2021
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and …
FDA Devices Moderate Jan 6, 2021
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of…
FDA Devices Moderate Jan 6, 2021
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. Th…
FDA Devices Moderate Jan 6, 2021
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. …
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…
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 U…
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 U…
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…
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 Sol…
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) the…
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…
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, M…
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 radi…
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 Sh…
FDA Devices Moderate Jan 11, 2017
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate t…
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 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 int…
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 prov…
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 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…
FDA Devices Moderate Jan 8, 2014
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once th…
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 c…
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…
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…
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 o…
FDA Drug Critical Nov 14, 2012