Recall archive
54 recalls · page 2 of 3
Reported Nov 25, 2020
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath…
FDA (openFDA device enforcement)
Reported May 6, 2020
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the…
FDA (openFDA device enforcement)
Reported Apr 22, 2020
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
FDA (openFDA device enforcement)
Reported Oct 9, 2019
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2018
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — Supplier manufacturing defect with the syringe plunger tip.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 28, 2018
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2018
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent…
FDA (openFDA device enforcement)
Reported May 3, 2017
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
FDA (openFDA device enforcement)
Reported Apr 19, 2017
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the…
FDA (openFDA device enforcement)
Reported Apr 5, 2017
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Merit Medical Systems, Inc.
Matched: Brand · Product details · Reason for recall — Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath…
FDA (openFDA device enforcement)
Reported Jan 11, 2017
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner…
FDA (openFDA device enforcement)
Reported Nov 30, 2016
Fluid Management Set. Catalog Number K08-MP5159A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2016
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details · Reason for recall — Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling…
FDA (openFDA device enforcement)
Reported Aug 19, 2015
ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Reason for recall — Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage…
FDA (openFDA device enforcement)
Reported Jul 1, 2015
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of…
FDA (openFDA device enforcement)
Reported Nov 12, 2014
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
FDA (openFDA device enforcement)
Reported Apr 30, 2014
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details · Reason for recall — Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2014
Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand — The products are labeled as sterile but were not sterilized.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details — Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate…
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details · Reason for recall — Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label…
FDA (openFDA device enforcement)
Reported Jan 8, 2014
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
Matched: Brand · Product · Product details · Reason for recall — Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel.…
FDA (openFDA device enforcement)
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