Matched: Brand — 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies,…

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 28, 2026

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand · Product · Product details — Inflation device handle may detach from the syringe during procedure.

6 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 26, 2025

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in…

FDA (openFDA device enforcement)

Medical devices

Reported Sep 17, 2025

10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the…

FDA (openFDA device enforcement)

Medical devices

Reported Aug 20, 2025

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use…

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 30, 2025

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand · Product · Product details — Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 2, 2025

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure…

FDA (openFDA device enforcement)

Medical devices

Reported Oct 23, 2024

Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

15 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 2, 2024

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — 7F sheath introducers labeled as 7.5F

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid…

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 — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…

22 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jul 3, 2024

Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may…

FDA (openFDA device enforcement)

Medical devices

Reported May 29, 2024

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 10, 2024

Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,…

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 — The sterility of microcatheter and infusion system devices cannot be guaranteed.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jun 21, 2023

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — There is a potential that valve assemblies will not open. preventing fluid from draining.

12 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 17, 2023

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Custom sheath Introducer contains incorrect needle size

FDA (openFDA device enforcement)

Medical devices

Reported Apr 19, 2023

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Product that was built for design verification testing was inadvertently distributed to customers.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 2, 2022

CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B,…

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 — Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Apr 20, 2022

Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 18, 2021

Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand · Product details — There is a potential that 7F sheaths are packaged as 10F sheaths.

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 4, 2021

basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand — Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

FDA (openFDA device enforcement)

Medical devices

Reported Mar 24, 2021

HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand · Reason for recall — The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jan 6, 2021

Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Merit Medical Systems, Inc.

Matched: Brand · Reason for recall — Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result…

2 more products in this recall

FDA (openFDA device enforcement)

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