Merit Medical Systems, Inc recalls
Every recall we track for Merit Medical Systems, Inc — 119 in all, from 2006–2026 — plus the complaints and injury reports the public filed about them. 6 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Merit Medical Systems, Inc fell by more than half in 2025 (16, down from 44 in 2024). 4% rated “stop using now”.
All FDA recall records for Merit Medical Systems, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 2 | 3 | 0 | 5 |
| 2018 | 0 | 0 | 4 | 0 | 4 |
| 2019 | 0 | 1 | 0 | 0 | 1 |
| 2020 | 0 | 4 | 5 | 0 | 9 |
| 2021 | 0 | 2 | 4 | 0 | 6 |
| 2022 | 0 | 2 | 2 | 0 | 4 |
| 2023 | 0 | 3 | 12 | 3 | 18 |
| 2024 | 3 | 18 | 23 | 0 | 44 |
| 2025 | 1 | 8 | 7 | 0 | 16 |
| 2026 (to date) | 1 | 4 | 5 | 1 | 11 |
Merit Medical Systems, Inc recalls before 2017
Recalls on record by year.
Most common reasons for Merit Medical Systems, Inc recalls
What to do if you have a recalled Merit Medical Systems, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Merit Medical Systems, Inc recalls
39 shown- Lower riskMedical device
Merit Medical Systems, Inc. recalls Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT
Merit Medical Systems recalls Scout MD Delivery System (MDS05A-01, MDS05C-01, MDS10C-01) due to potential clip deployment failures affecting surgical guidance.
Merit Medical SystemsAug 27, 2026 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2
Merit Medical Systems recalls 104 units of Embosphere 500-700 micrometer syringes with packaging holes that could lead to infection if used. Stop using immediately.
Merit Medical SystemsAug 10, 2026 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF:
Merit Medical recalls Splashwire Hydrophilic Guide Wire with unsealed pouches that may cause contamination during medical procedures. Affected units have specific UDI-DI codes and lot numbers. Consumers should contact Merit for details.
Merit MedicalMay 8, 2026 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Philips recalls Bridge Prep Kit REF K12-09098C (Sterile EO, Rx ONLY) due to catheter resistance during guidewire advancement. Affected units have specific lot numbers.
PhilipsApr 2, 2026 - Use cautionMedical device
Merit Medical Systems, Inc. recalls CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A,
Merit Medical Systems recalls CentrosFLO Hemodialysis Catheters with design defect that may not split properly, leading to bleeding, foreign bodies, or procedure delays. Affected models include CENFP15K/A through CENFT31K/D.
Merit Medical SystemsFeb 13, 2026 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Allwell Inflation Device, for angiographic use REF: IS-30-A
Merit Medical recalls Allwell Inflation Devices (REF: IS-30-A) for angiographic use due to risk of handle detaching during procedures. Affected units have specific UDI and lot numbers listed in the recall.
Merit MedicalDec 4, 2025 - Lower riskMedical device
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,
Merit Medical recalls PhD Hemostasis Valves with specific model numbers due to a manufacturing defect that may cause leakage, leading to procedure inconvenience or hemorrhage.
Merit MedicalAug 4, 2025 - Lower riskMedical device
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /
Merit Medical recalls 10Fore Hemostasis Valves with deformed silicone rings that may cause foreign bodies in fluid pathways. Affected units have specific catalog numbers and lot numbers.
Merit MedicalJul 25, 2025 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B,
Merit Medical recalls Custom Manifold Kits with specific model numbers due to high pressure tubing that may relax over time, potentially trapping air in the patient's line.
Merit MedicalJun 5, 2025 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical recalls EsophyX Z+ fastener delivery devices due to potential over-rotation and multiple fastener deployment risks. Affected units have specific lot numbers and require attention to prevent complications.
Merit MedicalMar 14, 2025 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Merit Medical recalls Prelude IDEAL 4F Hydrophilic Sheath Introducers that may contain 5F dilators, causing procedure delays. Affected units have specific reference numbers and expiration dates.
Merit MedicalJan 27, 2025 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM
Merit Medical recalls Melrose Wakefield Hospital 30 ATM angiographic injectors due to Tyvek barrier holes that could allow contamination. Affected units have specific lot numbers and were sold between 2021-2023.
Merit MedicalAug 30, 2024 - Use cautionMedical device
Merit Medical Systems, Inc. recalls basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Merit Medical recalls basixTOUCH Inflation Devices with possible small holes in sterile barriers that could expose users to pathogens, leading to infection. Affected units have specific model and lot numbers.
Merit MedicalAug 19, 2024 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
Merit Medical recalls Custom Procedure Kit REF K12T-11077 with 7F sheath introducers labeled as 7.5F. This mismatch may cause improper use during medical procedures.
Merit MedicalAug 12, 2024 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid
Merit Medical recalls convenience kits containing Jiangsu Shenli Medical syringes with leaks and breakage risks. Affected kits include specific model numbers and lot codes from March 2024. Consumers should check their kits for these identifiers.
Merit MedicalJun 11, 2024 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S
Recall of Prelude Roadster Guide Sheaths with specific model numbers due to risk of swivel nut detaching from HVA body if over-tightened during use.
Merit Medical SystemsMay 22, 2024 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical recalls Prelude Guide Sheath Roadster (PG5F45S018) due to potential inclusion of a .038 dilator instead of .018 in sterile surgical sheaths. Affected units sold with specific lot numbers.
Merit Medical SystemsMar 14, 2024 - UnratedMedical device
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB,
Merit Medical recalls certain Maestro Microcatheter models due to potential sterility issues. Affected devices may not be sterile, risking infection during medical procedures. Contact Merit Medical for details.
Merit MedicalNov 6, 2023 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Merit Medical recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF: 499:2509) due to potential valve failure preventing fluid drainage. Affected units have specific lot numbers and UDI-DI codes.
Merit Medical SystemsApr 22, 2023 - Use cautionMedical device
Merit Medical Systems, Inc. recalls COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Merit Medical recalls COBRA-OS custom sheath kits with incorrect needle size that could cause injury during medical procedures. Affected kits have specific lot numbers and were sold with a sterile, single-use label.
Merit MedicalMar 21, 2023 - UnratedMedical device
Merit Medical Systems, Inc. recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Merit Medical recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A distributed for design verification testing. This product was not intended for customer use.
Merit Medical SystemsFeb 15, 2023 - Use cautionMedical device
Merit Medical Systems, Inc. recalls CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B,
Merit Medical recalls CorVocet Biopsy Systems with specific catalog codes due to misaligned components that may cause needle ejection outside the body, leading to needle stick injuries.
Merit MedicalAug 3, 2022 - Lower riskMedical device
Merit Medical Systems, Inc. recalls AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863,
Merit Medical recalls AccessPLUS Large Bore Hemostasis Valves with a design gap that may cause guidewire delays during procedures. Affected models include catalog codes 580758001, 580774001, and others. No remedy specified in recall notice.
Merit MedicalMar 1, 2022 - Lower riskMedical device
Merit Medical Systems, Inc. recalls MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46
Merit Medical recalls Prelude Short Sheath Introducer (REF: PSS-6F-4-018MT) due to potential incorrect dilator in package. This may cause complications during medical procedures. Affected units were sold with specific model and lot numbers.
Merit MedicalJul 21, 2021 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx
Merit Medical recalls Prelude SNAP Splittable Sheath Introducer (REF: PLSX-1:10F) due to potential packaging error where 7F sheaths are shipped as 10F. This may cause incorrect use in medical procedures.
Merit Medical SystemsJun 30, 2021 - Use cautionMedical device
Merit Medical Systems, Inc. recalls basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or
Merit Medical recalls basixALPHA Inflation Devices 30 atm/bar 20 mL due to risk of handle separation during use. Affected units have specific catalog numbers and lot numbers listed in the recall notice.
Merit MedicalJun 10, 2021 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an
Merit Medical recalls Heartspan Transseptal Needles (Catalog FND-019-02, Lot E1913645) due to possible incorrect needle tip curvature causing unintended anatomy punctures requiring medical intervention.
Merit Medical SystemsJan 19, 2021 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For
Merit Medical recalls custom angiography kits due to potential non-sterile devices causing infections. Affected kits may have compromised sterile barriers. Consumers should contact Merit Medical for details.
Merit Medical SystemsNov 10, 2020 - Use cautionMedical device
Merit Medical Systems, Inc. recalls MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1
Merit Medical recalls Cultura Flex Swab (Ref C100F) due to flocked tip breaking off during use, potentially causing soft tissue injury or treatment delays. Affected units sold before August 28, 2020.
Merit MedicalSep 16, 2020 - Use cautionMedical device
Merit Medical Systems, Inc. recalls PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Merit Medical recalls PreludeSYNC DISTAL Radial Compression Devices (SDRB-REG-LT/RT) due to risk of balloon burst during sterilization causing bleeding or treatment delays. Affected units have specific lot numbers.
Merit MedicalMar 11, 2020 - Lower riskMedical device
Merit Medical Systems, Inc. recalls DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System,
Merit Medical recalls vertebrae assembly products with incorrect 5-year expiration labels. These products may not function properly or require procedure rescheduling if used beyond their 2-year shelf life.
Merit MedicalFeb 13, 2020 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the
Merit Medical recalls Custom Sheath Introducer Kit REF K21-0: incorrect sheath size included may cause bleeding, clots, or blockages during medical procedures.
Merit Medical SystemsSep 12, 2019 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI:
Merit Medical recalls Custom Procedure Kit (K12T-03688) due to incorrect latex labeling. This may cause confusion about whether the kit is latex-free, but does not pose a safety risk.
Merit Medical SystemsOct 26, 2018 - Lower riskMedical device
Merit Medical Systems, Inc. recalls ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative
Merit Medical recalls ChloraPrep With Tint patient preop solution due to nonsterile bulk product shipped to customers. This may pose infection risks during surgery preparation.
Merit MedicalJul 9, 2018 - Lower riskMedical device
Merit Medical Systems, Inc. recalls 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Merit Medical recalls 1mL Medallion Syringes due to a supplier manufacturing defect in the plunger tip. Affected units have specific catalog and lot numbers listed in the recall notice.
Merit MedicalFeb 2, 2018 - Use cautionMedical device
Merit Medical Systems, Inc. recalls Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for
Merit Medical recalls pediatric peritoneal dialysis catheters due to potential mix-up with adult models. Check lot numbers H1027245 to H99507: if your child uses this catheter, stop using it immediately.
Merit MedicalDec 20, 2017 - Use cautionMedical device
Merit Medical Systems, Inc. recalls PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008,
Merit Medical recalls specific PreludeSNAP Splittable Sheath Introducers due to intermittent splittable hub failure. Affected models include PLS-1007 to PLSX-1009.5 with certain lot numbers. Consumers should contact Merit Medical for details.
Merit MedicalDec 14, 2017 - Lower riskMedical device
Merit Medical Systems, Inc. recalls Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant
Merit Medical recalls Custom Dialysis Kit CF-4235 Without Gel due to incorrect cuff labeling. This may cause improper dialysis setup. Affected units include specific lot numbers and expiration dates.
Merit Medical SystemsSep 20, 2017 - Stop using nowDrug
Merit Medical Systems, Inc recalls Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC
Merit Medical Systems recalls 2,470 convenience kits containing Cytosol Balanced Salt Solution due to potential endotoxin contamination.
Merit Medical SystemsFeb 24, 2006
Merit Medical Systems, Inc recall questions
How many recalls has Merit Medical Systems, Inc had?
119 recalls from Merit Medical Systems, Inc are on record with U.S. safety agencies, from 2006–2026 (118 medical device, 1 drug).
What is the most recent Merit Medical Systems, Inc recall?
Merit Medical Systems, Inc. recalls Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT, dated Aug 27, 2026. Every Merit Medical Systems, Inc recall is listed on this page, newest first.
Why are Merit Medical Systems, Inc products recalled?
The most common reasons on record: Inflation device handle may detach from the syringe during procedure. (7); catheter may experience resistance when being advanced over the guidewire (3); The sterility of microcatheter and infusion system devices cannot be guaranteed. (3); 7F sheath introducers labeled as 7.5F (2).
What should I do if I have a recalled Merit Medical Systems, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Merit Medical Systems, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.