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
January 10, 2024FDAMerit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113…Z-0627-2024
January 10, 2024FDAMerit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A…Z-0628-2024
January 10, 2024FDAFountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLYZ-0629-2024
January 6, 2021FDAProduct Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884…Z-0749-2021
January 6, 2021FDACustom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx …Z-0751-2021
May 6, 2020FDAPreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RTZ-1796-2020
May 3, 2017FDA1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, M…Z-1889-2017
April 19, 2017FDAThe PreludeSYNC Radial Compression Device is a sterile, single use disposable device used…Z-1766-2017
April 5, 2017FDA7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035M…Z-1497-2017
January 11, 2017FDAPreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Shea…Z-0949-2017
April 20, 2016FDABoston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the pr…Z-1375-2016
November 12, 2014FDAMerit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic …Z-0162-2015
April 30, 2014FDAMerit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaf…Z-1485-2014
April 30, 2014FDAMerit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalo…Z-1486-2014
April 9, 2014FDAMerit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.Z-1320-2014
April 9, 2014FDAPressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used betw…Z-1319-2014
February 26, 2014FDAMerit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, US…Z-0980-2014
February 5, 2014FDARadial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for …Z-0901-2014
January 8, 2014FDACatheter, Continuous Flush The Merit Microcatheter is intended for general intravascular…Z-0614-2014
October 30, 2013FDAMerit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560…Z-0045-2014
July 10, 2013FDACustom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combi…Z-1660-2013
June 5, 2013FDAMerit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic…Z-1408-2013
February 27, 2013FDAMerit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RB…Z-0866-2013
January 16, 2013FDAMerit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom …Z-0663-2013
December 12, 2012FDACustom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pa…Z-0464-2013

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.
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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