FDA recall record · openFDA
Merit Medical Systems, Inc.
86 FDA recalls on record (2023–2026) — 86 device. 86 still ongoing.
5
Class I (most serious)
81
Class II
0
Class III
86
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, brea 23
There is a potential that valve assemblies will not open. preventing fluid from draining. 13
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in e 10
Inflation device handle may detach from the syringe during procedure. 7
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. 6
Recalls
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K Class I 2026-02-13 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, Class I 2026-02-13 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B Class I 2026-02-13 BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96 Class I 2026-02-13 DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030 Class I 2026-02-13 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY Class II 2026-04-02 Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY Class II 2026-04-02 Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY Class II 2026-04-02 Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly Class II 2025-03-14 Allwell Inflation Device, for angiographic use REF: IS-30-A Class II 2025-12-04 Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130 Class II 2025-12-04 Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Class II 2025-01-27 Merit Medical , Custom Manifold Kit REF: K09-13203A Class II 2025-12-04 Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 Class II 2025-12-04 Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05 Class II 2025-12-04 Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334 Class II 2025-06-05 Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 Class II 2025-06-05 Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca Class II 2025-03-14 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / Class II 2025-07-25 Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B Class II 2025-12-04 High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C Class II 2025-06-05 Allwell Angioplasty Pack REF: IS-30-B1/B Class II 2025-12-04 PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, Class II 2025-08-04 Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP Class II 2025-06-05 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre Class II 2024-06-11 basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C Class II 2024-08-19 Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY Class II 2024-03-14 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22 Class II 2024-06-11 Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M Class II 2024-08-30 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09 Class II 2024-06-11 Custom Procedure Kit, REF: K12T-11077 Class II 2024-08-12 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 Class II 2024-06-11 Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410 Class II 2024-08-19 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 Class II 2024-06-11 Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY Class II 2024-03-14 basixSKY Inflation Device, REF: SKY1802 Class II 2024-08-19 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf Class II 2024-06-11 Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF Class II 2024-08-30 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12 Class II 2024-06-11 MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B Class II 2024-08-19 DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A Class II 2024-08-19 Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S Class II 2024-05-22 Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3 Class II 2024-08-30 Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C Class II 2024-08-19 Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto Class II 2024-08-30 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10 Class II 2024-06-11 BlueFIRE Inflation Device, REF: IN10140 Class II 2024-08-19 Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injec Class II 2024-08-30 basixTOUCH Inflation Device, REF: IN8140/A Class II 2024-08-19 StabiliT TOUCH Syringe, REF: IN8VCF/B Class II 2024-08-19 IntelliSystem Inflation Device, REF: IN1525/D Class II 2024-08-19 Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) Class II 2024-08-12 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08 Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out Class II 2024-06-11 Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In Class II 2024-08-30 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf Class II 2024-06-11 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus Class II 2024-06-11 Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2 Class II 2023-11-06 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only Class II 2023-04-22 Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE Class II 2023-11-06 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only Class II 2023-04-22 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only Class II 2023-04-22 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only Class II 2023-04-22 Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A Class II 2023-02-15 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only Class II 2023-04-22 COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units Class II 2023-03-21 Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only Class II 2023-04-22 Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY Class II 2023-11-06 Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only Class II 2023-04-22 Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only Class II 2023-04-22
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.