Merit Medical Systems recalls
22 official recalls and safety alerts involving Merit Medical Systems since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Merit Medical Systems or the relevant agency.
- 2026-10-07
USMerit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe…
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of CA, GA and the…Official notice →- 2026-06-24
- US
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180…
Due to unsealed portions of pouches.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ,…Official notice → - 2026-05-06
- US
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA · DeviceMerit Medical Systems, Inc.US Nationwide distribution in the state of CO.Official notice → - 2026-04-01
- US
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K,…
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss…
FDA · DeviceMerit Medical Systems, Inc.Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL,…Official notice → - 2026-01-28
- US
Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ,…Official notice → - 2025-11-26
- US
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A,…
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
FDA · DeviceMerit Medical Systems, Inc.US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS,…Official notice → - 2025-09-17
- US
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329…
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 fluid pathway.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY,…Official notice → - 2025-08-20
- US
Merit Medical Systems, Inc. recalls Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP,…
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 of the affected product may result in the trapped air being introduced…
FDA · DeviceMerit Medical Systems, Inc.US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI,…Official notice → - 2025-04-30
- US
Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2025-04-02
- US
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
FDA · DeviceMerit Medical Systems, Inc.International distribution to the country of Japan.Official notice → - 2024-10-23
- US
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe…
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2024-10-02
- US
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - 2024-08-21
- US
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2024-07-03
- US
Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS…
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 cause users to over-tightening the luer which may result in the swivel…
FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-05-29
- US
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice → - 2024-01-10
- US
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B,…
The sterility of microcatheter and infusion system devices cannot be guaranteed.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT,…Official notice → - 2023-06-21
- US
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - 2023-05-17
- US
Merit Medical Systems, Inc. recalls COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Custom sheath Introducer contains incorrect needle size
- 2023-04-19
- US
Merit Medical Systems, Inc. recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Product that was built for design verification testing was inadvertently distributed to customers.
FDA · DeviceMerit Medical Systems, Inc.U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/AOfficial notice → - 2022-11-02
- US
Merit Medical Systems, Inc. recalls CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A,…
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient…
FDA · DeviceMerit Medical Systems, Inc.Worldwide distribution - US National distribution including in the states of…Official notice → - 2022-04-20
- US
Merit Medical Systems, Inc. recalls AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A,…
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire…
FDA · DeviceMerit Medical Systems, Inc.US: MN, PA, AZ, FL, IL, AK, NY, CA, TX, KY, WI, NC, NJ, VA, CO, IN, AR, MO,…Official notice →