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Merit Medical Systems, Inc Recalls

92 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Merit Medical Systems, Inc.

92Total Recalls
6Critical
11.9MUnits Affected
Apr 2, 2026Most Recent
All Recalls

Every Merit Medical Systems, Inc Recall

Sorted by most recent. Click any recall for full details.

92 recalls
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·2 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Surgical Devices·175 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Surgical Devices·524 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Surgical Devices·436 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Surgical Devices·27 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Surgical Devices·17 affected·Feb 15, 2023
High RiskFDA
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CO...
Medical Devices·1,822 affected·Aug 3, 2022
High RiskFDA
Merit Medical Systems, Inc.
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, Sing...
Medical Devices·373 affected·Jul 21, 2021
High RiskFDA
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 008844504...
Cardiac Devices·760 affected·Jun 30, 2021
High RiskFDA
Merit Medical Systems, Inc.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional ...
Medical Devices·7,211 affected·Jun 10, 2021
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The...
Surgical Devices·90 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angi...
Cardiac Devices·80 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/a...
Surgical Devices·42 affected·Nov 10, 2020
High RiskFDA
Merit Medical Systems, Inc.
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445...
Medical Devices·3,385,442 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450...
Medical Devices·159,396 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit...
Medical Devices·371,528 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Medical Devices·1,932 affected·Mar 11, 2020
High RiskFDA
Merit Medical Systems, Inc.
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introductio...
Medical Devices·15 affected·Sep 12, 2019
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Medical Devices·88 affected·Oct 26, 2018
High RiskFDA
Merit Medical Systems, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non...
Medical Devices·6 affected·Jul 9, 2018
High RiskFDA
Merit Medical Systems, Inc.
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Medical Devices·22,234 affected·Feb 2, 2018
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialy...
Medical Implants·0 affected·Dec 20, 2017
High RiskFDA
Merit Medical Systems, Inc.
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, P...
Medical Devices·60,945 affected·Dec 14, 2017
High RiskFDA
Merit Medical Systems, Inc.
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, M...
Medical Devices·23,032 affected·Mar 23, 2017
High RiskFDA
Merit Medical Systems, Inc.
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis...
Surgical Devices·1,940 affected·Mar 3, 2017
CriticalFDA
Merit Medical Systems, Inc.
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelu...
Diagnostic Devices·1,265 affected·Feb 16, 2017
High RiskFDA
Merit Medical Systems, Inc.
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and ...
Diagnostic Devices·335 affected·Dec 1, 2016
High RiskFDA
Merit Medical Systems, Inc.
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Medical Devices·130 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Manifold Kit. Catalog Number K09-11867AP
Medical Devices·40 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Medical Devices·53 affected·Sep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Medical Devices·1,297 affected·Aug 25, 2016
High RiskFDA
Merit Medical Systems, Inc.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when pa...
Cardiac Devices·25 affected·Mar 15, 2016
High RiskFDA
Merit Medical Systems, Inc.
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
Surgical Devices·950 affected·Jun 29, 2015
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is inte...
Diagnostic Devices·1,445 affected·Jun 4, 2015
High RiskFDA
Merit Medical Systems, Inc.
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Medical Devices·186 affected·Apr 14, 2014
High RiskFDA
Merit Medical Systems, Inc.
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Medical Devices·15 affected·Mar 13, 2014
High RiskFDA
Merit Medical Systems, Inc.
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculat...
Surgical Devices·59 affected·Dec 6, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Surgical Devices·200 affected·Sep 13, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for deliverin...
Surgical Devices·1,465 affected·May 2, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary...
Surgical Devices·387 affected·Jan 16, 2013
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices place...
Medical Devices·134 affected·Nov 21, 2012
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of lega...
Medical Devices·422 affected·Sep 14, 2012
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a c...
Medical Devices·83 affected·Jun 8, 2012
CriticalFDA
Merit Medical Systems, Inc
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Ophthalmic Drugs·2,470 affected·Feb 24, 2006