PlainRecalls

Merit Medical Systems, Inc

Compiled from official public sources by the editorial team.

144 recalls on record · Latest: May 6, 2026

Merit Medical Systems, Inc Recall Insight

Merit Medical Systems, Inc appears on 144 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.142% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 5 critical, 45 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 46 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Aug 21, 2024 to May 6, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

FDA Devices Moderate May 6, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

FDA Devices Critical Apr 1, 2026

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CEN…

FDA Devices Critical Apr 1, 2026

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

FDA Devices Critical Apr 1, 2026

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

FDA Devices Critical Apr 1, 2026

BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/E…

FDA Devices Critical Apr 1, 2026

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H78…

FDA Devices Moderate Jan 28, 2026

Allwell Inflation Device, for angiographic use REF: IS-30-A

FDA Devices Moderate Jan 28, 2026

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN41…

FDA Devices Moderate Jan 28, 2026

Merit Medical , Custom Manifold Kit REF: K09-13203A

FDA Devices Moderate Jan 28, 2026

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

FDA Devices Moderate Jan 28, 2026

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C…

FDA Devices Moderate Jan 28, 2026

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

FDA Devices Moderate Jan 28, 2026

Allwell Angioplasty Pack REF: IS-30-B1/B

FDA Devices Moderate Nov 26, 2025

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800…

FDA Devices Moderate Sep 17, 2025

10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore…

FDA Devices Moderate Aug 20, 2025

Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, …

FDA Devices Moderate Aug 20, 2025

Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

FDA Devices Moderate Aug 20, 2025

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

FDA Devices Moderate Aug 20, 2025

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

FDA Devices Moderate Apr 30, 2025

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

FDA Devices Moderate Apr 30, 2025

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

FDA Devices Moderate Apr 2, 2025

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

FDA Devices Moderate Oct 23, 2024

basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C

FDA Devices Moderate Oct 23, 2024

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inf…

FDA Devices Moderate Oct 23, 2024

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K0…

FDA Devices Moderate Oct 23, 2024

basixSKY Inflation Device, REF: SKY1802

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syrin…

FDA Devices Moderate Oct 23, 2024

MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B

FDA Devices Moderate Oct 23, 2024

DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used…

FDA Devices Moderate Oct 23, 2024

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/S…

FDA Devices Moderate Oct 23, 2024

BlueFIRE Inflation Device, REF: IN10140

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic…

FDA Devices Moderate Oct 23, 2024

basixTOUCH Inflation Device, REF: IN8140/A

FDA Devices Moderate Oct 23, 2024

StabiliT TOUCH Syringe, REF: IN8VCF/B

FDA Devices Moderate Oct 23, 2024

IntelliSystem Inflation Device, REF: IN1525/D

FDA Devices Moderate Oct 23, 2024

Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiograp…

FDA Devices Moderate Oct 2, 2024

Custom Procedure Kit, REF: K12T-11077

FDA Devices Moderate Oct 2, 2024

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management …

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Cathete…

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit)…

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fl…

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), …

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K0…

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring …

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tr…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Merit Medical Systems, Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.