South Jordan, UT, United States
Merit Medical Systems, Inc. recalls
38 recalls recorded since 2018, most recently on 27 August 2026. 23 are listed as ongoing. Status and classification are as published by the FDA.
Recalls38
Ongoing (FDA)23
Terminated or completed15
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 27 August 2026
- Reason
- The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
- Distribution
- US: AZ, CA, FL, IN, LA, NV, RI OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0187-2027
- Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Ongoing Class II Medical devices
- Recall started
- 10 August 2026
- Reason
- Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3305-2026
- Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Steril
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- Reason
- Due to unsealed portions of pouches.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. The countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2517-2026
- Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code
Ongoing Class II Medical devices
- Recall started
- 2 April 2026
- Reason
- catheter may experience resistance when being advanced over the guidewire
- Distribution
- US Nationwide distribution in the state of CO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2003-2026, Z-2002-2026, Z-2004-2026
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
- Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Ongoing Class I Medical devices
- Recall started
- 13 February 2026
- Reason
- 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
- Distribution
- Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirat
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1575-2026, Z-1576-2026, Z-1577-2026, Z-1579-2026, Z-1578-2026
- CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT1
- ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
- BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU
- DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H78710
Ongoing Class II Medical devices
- Recall started
- 4 December 2025
- Reason
- Inflation device handle may detach from the syringe during procedure.
- Distribution
- Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1124-2026, Z-1123-2026, Z-1127-2026, Z-1125-2026, Z-1126-2026, Z-1128-2026, Z-1129-2026
- Allwell Inflation Device, for angiographic use REF: IS-30-A
- 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 IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K
- Merit Medical , Custom Manifold Kit REF: K09-13203A
- Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
- 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 K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K0
- Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
- Allwell Angioplasty Pack REF: IS-30-B1/B
Ongoing Class II Medical devices
- Recall started
- 4 August 2025
- Reason
- Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
- Distribution
- US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Nethe
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0533-2026
- 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/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY18
Ongoing Class II Medical devices
- Recall started
- 25 July 2025
- Reason
- Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2553-2025
- 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introd
Ongoing Class II Medical devices
- Recall started
- 5 June 2025
- Reason
- High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Distribution
- US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2295-2025, Z-2294-2025, Z-2293-2025, Z-2296-2025
- Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
- Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
- High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
- Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Ongoing Class II Medical devices
- Recall started
- 14 March 2025
- Reason
- Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1640-2025, Z-1641-2025
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Ongoing Class II Medical devices
- Recall started
- 27 January 2025
- Reason
- Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1434-2025
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Ongoing Class II Medical devices
- Recall started
- 30 August 2024
- Reason
- Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Ja
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0062-2025, Z-0061-2025, Z-0057-2025, Z-0060-2025, Z-0059-2025, Z-0058-2025
- Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the press
- Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syring
- Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure th
- Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to infla
- Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inf
- Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to
Ongoing Class II Medical devices
- Recall started
- 19 August 2024
- Reason
- Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaic
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0072-2025, Z-0070-2025, Z-0071-2025, Z-0069-2025, Z-0066-2025, Z-0064-2025, Z-0068-2025, Z-0065-2025, Z-0073-2025, Z-0067-2025
- basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
- Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K
- basixSKY Inflation Device, REF: SKY1802
- MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
- DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
- Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
- BlueFIRE Inflation Device, REF: IN10140
- basixTOUCH Inflation Device, REF: IN8140/A
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 August 2024
- Reason
- 7F sheath introducers labeled as 7.5F
- Distribution
- Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3191-2024, Z-3190-2024
- Custom Procedure Kit, REF: K12T-11077
- Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Ongoing Class II Medical devices
- Recall started
- 11 June 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2557-2024, Z-2574-2024, Z-2568-2024, Z-2569-2024, Z-2564-2024, Z-2561-2024, Z-2566-2024, Z-2576-2024, Z-2578-2024, Z-2562-2024, Z-2579-2024, Z-2570-2024 and 11 more
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a d
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A Th
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K0
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to adm
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L
- and 15 more product lines
Ongoing Class II Medical devices
- Recall started
- 22 May 2024
- Reason
- Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Brazil,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2218-2024
- Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX
Ongoing Class II Medical devices
- Recall started
- 14 March 2024
- Reason
- Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1874-2024, Z-1875-2024
- Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
- Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Ongoing Class II Medical devices
- Recall started
- 6 November 2023
- Reason
- The sterility of microcatheter and infusion system devices cannot be guaranteed.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0627-2024, Z-0628-2024, Z-0629-2024
- Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110
- Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
- Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Ongoing Class II Medical devices
- Recall started
- 22 April 2023
- Reason
- There is a potential that valve assemblies will not open. preventing fluid from draining.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Ki
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1915-2023, Z-1917-2023, Z-1919-2023, Z-1912-2023, Z-1920-2023, Z-1910-2023, Z-1913-2023, Z-1914-2023, Z-1909-2023, Z-1908-2023, Z-1918-2023, Z-1916-2023 and 1 more
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
- Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
- Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
- Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
- Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 21 March 2023
- Reason
- Custom sheath Introducer contains incorrect needle size
- Distribution
- US Distribution to state of: Minnesota
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1578-2023
- COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Ongoing Class II Medical devices
- Recall started
- 15 February 2023
- Reason
- Product that was built for design verification testing was inadvertently distributed to customers.
- Distribution
- U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1352-2023
- Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Ongoing Class II Medical devices
- Recall started
- 3 August 2022
- Reason
- Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
- Distribution
- Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emira
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0137-2023, Z-0138-2023
- CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B
- CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820S
Ongoing Class II Medical devices
- Recall started
- 1 March 2022
- Reason
- A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.
- Distribution
- US: MN, PA, AZ, FL, IL, AK, NY, CA, TX, KY, WI, NC, NJ, VA, CO, IN, AR, MO, LA, OR, MT, MA, MI, NE, WV, KS, MS, HI, IA, NH, ME, AL, DC, DE, NM, OH, GA, MD, TN, UT, RI, SC, OK, WA, ID, ND, SD, NV, VT. OUS: Poland, Germany, France, United Kingdom, Belgium, Korea, Republic of, Austria, Canada, Spain,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0904-2022, Z-0903-2022
- AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12
- Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-1
Terminated Class II Medical devices
- Recall started
- 21 July 2021
- Terminated
- 13 March 2023
- Reason
- There is a potential that a package sheath contains an incorrect dilator.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2243-2021
- MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Terminated Class II Medical devices
- Recall started
- 30 June 2021
- Terminated
- 24 February 2023
- Reason
- There is a potential that 7F sheaths are packaged as 10F sheaths.
- Distribution
- US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2238-2021, Z-2239-2021
- Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the h
- Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the
Terminated Class II Medical devices
- Recall started
- 10 June 2021
- Terminated
- 15 May 2024
- Reason
- Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2166-2021
- basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Terminated Class II Medical devices
- Recall started
- 19 January 2021
- Terminated
- 17 May 2022
- Reason
- The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an unintended anatomy puncture may occur, which is likely to require medical intervention.
- Distribution
- U.S. Consignees: VA, NE, Washington DC, MI, NY, KY, CA, TX, MD, AL, GA, UT, LA, CA, CT, PA, WA, MT and NJ. No government consignees. Also distributed OUS.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1263-2021, Z-1262-2021
- Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock
- HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock
Terminated Class II Medical devices
- Recall started
- 10 November 2020
- Terminated
- 5 October 2022
- Reason
- Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
- Distribution
- US distribution to: KY, RI, and MD
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0749-2021, Z-0751-2021, Z-0750-2021
- Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, vario
- Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups
- Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups
Terminated Class II Medical devices
- Recall started
- 16 September 2020
- Terminated
- 1 June 2021
- Reason
- The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
- Distribution
- Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0454-2021, Z-0455-2021, Z-0456-2021
- MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
- Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
- Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (0
Terminated Class II Medical devices
- Recall started
- 11 March 2020
- Terminated
- 2 March 2022
- Reason
- During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
- Distribution
- U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1796-2020
- PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Terminated Class II Medical devices
- Recall started
- 13 February 2020
- Terminated
- 26 February 2021
- Reason
- Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.
- Distribution
- Worldwide distribution: US Nationwide distribution including in the states of (TX, UT, PA, KY, TX, AR, CA, and PA) which included one (1) government/military consignee in KY; and the countries of (Germany, Switzerland, and New Zealand).
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2068-2020, Z-2067-2020
- DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in k
- DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphop
Terminated Class II Medical devices
- Recall started
- 12 September 2019
- Terminated
- 27 May 2022
- Reason
- labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
- Distribution
- US Nationwide distribution in the state of MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1956-2020
- Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Terminated Class II Medical devices
- Recall started
- 26 October 2018
- Terminated
- 12 June 2020
- Reason
- Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
- Distribution
- U.S.: VA, IL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0026-2020, Z-0027-2020
- Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
- Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Terminated Class II Medical devices
- Recall started
- 9 July 2018
- Terminated
- 14 April 2020
- Reason
- A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
- Distribution
- US Nationwide distribution in the state of IL. There was no other distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1702-2020
- ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No.
Terminated Class II Medical devices
- Recall started
- 2 February 2018
- Terminated
- 30 November 2020
- Reason
- Supplier manufacturing defect with the syringe plunger tip.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2742-2018
- 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Terminated Class II Medical devices
- Recall started
- 20 December 2017
- Terminated
- 29 October 2020
- Reason
- Mix-up between adult and pediatrics PD catheter.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT and the countries of Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2823-2018
- Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or
Terminated Class II Medical devices
- Recall started
- 14 December 2017
- Terminated
- 10 July 2020
- Reason
- Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
- Distribution
- US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0688-2018
- PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PL
Terminated Class II Medical devices
- Recall started
- 20 September 2017
- Reason
- 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
- Distribution
- United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1144-2018, Z-1143-2018, Z-1145-2018
- Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
- Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
- Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.