Merit Medical Systems, Inc.: 76 recalls on record

Recalls filed with 1 agency: FDA (76).

First recall on record: November 14, 2012. Most recent: June 24, 2026.

Risk classification: Class I: 3 · Class II: 73

Most recent recalls

DateAgencyProduct
June 24, 2026FDASplashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 008…Z-2517-2026
May 6, 2026FDAPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYZ-2004-2026
May 6, 2026FDAPhilips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYZ-2002-2026
May 6, 2026FDAPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYZ-2003-2026
April 30, 2025FDAMerit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnlyZ-1640-2025
April 2, 2025FDAPrelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/DZ-1434-2025
October 23, 2024FDADiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/AZ-0066-2025
October 23, 2024FDABlue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN785…Z-0064-2025
October 23, 2024FDAbasixSKY Inflation Device, REF: SKY1802Z-0071-2025
October 23, 2024FDAMonarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool To…Z-0059-2025
October 23, 2024FDAbasixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8…Z-0072-2025
October 23, 2024FDAMonarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syr…Z-0057-2025
October 23, 2024FDAMelrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, B…Z-0062-2025
October 23, 2024FDAIntelliSystem Inflation Device, REF: IN1525/DZ-0067-2025
October 23, 2024FDAMonarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal I…Z-0061-2025
October 23, 2024FDAStabiliT TOUCH Syringe, REF: IN8VCF/BZ-0073-2025
October 23, 2024FDAMonarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Too…Z-0058-2025
October 23, 2024FDACustom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K0…Z-0070-2025
October 23, 2024FDABlueFIRE Inflation Device, REF: IN10140Z-0068-2025
October 23, 2024FDAbasixTOUCH Inflation Device, REF: IN8140/AZ-0065-2025
October 23, 2024FDAMonarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torq…Z-0060-2025
October 23, 2024FDAMONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/BZ-0069-2025
October 2, 2024FDAPrelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)Z-3190-2024
October 2, 2024FDACustom Procedure Kit, REF: K12T-11077Z-3191-2024
August 21, 2024FDAVarious Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produ…Z-2565-2024

Questions about this company

How many recalls does Merit Medical Systems, Inc. have?
Recalert has 76 U.S. recalls on record for Merit Medical Systems, Inc., published between November 14, 2012 and June 24, 2026.
What was the most recent Merit Medical Systems, Inc. recall?
FDA recall Z-2517-2026, published June 24, 2026: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTD…
Which agencies have handled Merit Medical Systems, Inc. recalls?
Merit Medical Systems, Inc. appears as the recalling firm in recalls from: FDA (76).

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