Merit Medical Systems recalls

Merit Medical Systems has 145 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 7 Oct 2026. 91 are still ongoing. 18 were reported in the last 12 months.

Total recalls145since 2012

Last 12 months18reported

Class I86% of total

Ongoing91latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 3 0May 0 0 4Aug 1 0 1Nov 0 7 0Feb 0 5 3May 1 0 0Aug 0 1

Severity split

Class I 8 6%Class II 137 94%Class III 0 0%

Why merit medical systems is recalled

Product types

By year

20261712%
202596%
20244632%
20231510%
202243%
202196%
202086%
201921%
201864%
201743%

Ongoing merit medical systems recalls

91 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
24 Jun 2026Device	CLASS II	Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems	Merit Medical Systems	Packaging Defects	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
1 Apr 2026Device	CLASS I	DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide

All merit medical systems recalls, newest first

145 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
24 Jun 2026Device	CLASS II	Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems	Merit Medical Systems	Packaging Defects	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
6 May 2026Device	CLASS II	Philips Bridge Prep Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
1 Apr 2026Device	CLASS I	DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	BioFlo DuraMax Catheter recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile) recalled	Merit Medical Systems	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	ProGuide Chronic Dialysis Catheters recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	CentrosFLO Hemodialysis Catheters recalled by Merit Medical Systems	Merit Medical Systems	Device Malfunction	Nationwide
28 Jan 2026Device	CLASS II	Allwell Angioplasty Pack recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Merit Medical , Custom Procedure Kit Reference Numbers recalled	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Merit Medical , Custom Inflation Kit recalled	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Merit Medical , Custom Waste Management Kit Vascular Tray recalled	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Merit Medical , Custom Manifold Kit recalled	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Merit Medical Inflation Device.basixCOMPAK.30 atm/bar recalled	Merit Medical Systems	Other	Nationwide
28 Jan 2026Device	CLASS II	Allwell Inflation Device, for angiographic use recalled	Merit Medical Systems	Other	Nationwide
26 Nov 2025Device	CLASS II	PhD Hemostasis Valve recalled by Merit Medical Systems	Merit Medical Systems	Packaging Defects	50 states
17 Sep 2025Device	CLASS II	10Fore Hemostasis Valve recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
20 Aug 2025Device	CLASS II	Custom Waste Management Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
20 Aug 2025Device	CLASS II	High Pressure Tubing recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
20 Aug 2025Device	CLASS II	Custom Tubing Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
20 Aug 2025Device	CLASS II	Custom Manifold Kit recalled by Merit Medical Systems	Merit Medical Systems	Other	Nationwide
30 Apr 2025Device	CLASS II	Merit Medical recalled	Merit Medical Systems	Other	Nationwide
30 Apr 2025Device	CLASS II	Merit Medical recalled	Merit Medical Systems	Other	Nationwide
2 Apr 2025Device	CLASS II	Prelude Ideal 4 F Hydrophilic Sheath Introducer recalled	Merit Medical Systems	Other	UT
23 Oct 2024Device	CLASS II	Monarch Inflation Device MAP 112 Access-9 Large Bore recalled	Merit Medical Systems	Sterility	Nationwide
23 Oct 2024Device	CLASS II	IntelliSystem Inflation Device recalled by Merit Medical Systems	Merit Medical Systems	Sterility	Nationwide
23 Oct 2024Device	CLASS II	StabiliT Touch Syringe recalled by Merit Medical Systems	Merit Medical Systems	Sterility	Nationwide
23 Oct 2024Device	CLASS II	basixTOUCH Inflation Device recalled by Merit Medical Systems	Merit Medical Systems	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.