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Is Merit Medical Systems recalled?

Merit Medical Systems recalls - full list & free alerts

Official U.S. agency records list 18 recalls involving Merit Medical Systems in the last 12 months, most recently on 2026-10-07. Check each official notice for the exact products, lot codes and dates affected.

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Recalls (18)

Merit Medical Systems, Inc.: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Steri
Medical DevicesFDA (device) · 2026-10-07 · Class II
Merit Medical Systems, Inc.: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 U
Medical DevicesFDA (device) · 2026-06-24 · Class II
Merit Medical Systems, Inc.: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Medical DevicesFDA (device) · 2026-05-06 · Class II
Merit Medical Systems, Inc.: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Medical DevicesFDA (device) · 2026-05-06 · Class II
Merit Medical Systems, Inc.: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Medical DevicesFDA (device) · 2026-05-06 · Class II
Merit Medical Systems, Inc.: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT1
Medical DevicesFDA (device) · 2026-04-01 · Class I
Merit Medical Systems, Inc.: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Medical DevicesFDA (device) · 2026-04-01 · Class I
Merit Medical Systems, Inc.: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Medical DevicesFDA (device) · 2026-04-01 · Class I
Merit Medical Systems, Inc.: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H7871030280
Medical DevicesFDA (device) · 2026-04-01 · Class I
Merit Medical Systems, Inc.: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H96510
Medical DevicesFDA (device) · 2026-04-01 · Class I
Merit Medical Systems, Inc.: Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Allwell Inflation Device, for angiographic use REF: IS-30-A
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K0
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Merit Medical , Custom Manifold Kit REF: K09-13203A
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: Allwell Angioplasty Pack REF: IS-30-B1/B
Medical DevicesFDA (device) · 2026-01-28 · Class II
Merit Medical Systems, Inc.: PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/
Medical DevicesFDA (device) · 2025-11-26 · Class II
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