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Merit Medical Systems Recalls
145 recalls on record · November 14, 2012 to June 24, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04
Hazard: 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.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04
Hazard: 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.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02
Hazard: 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.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out
Hazard: 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.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Hazard: 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.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap
Hazard: 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.
July 3, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S
Hazard: 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.
May 29, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Hazard: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
May 29, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Hazard: Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
June 21, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Hazard: There is a potential that valve assemblies will not open. preventing fluid from draining.
May 17, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Hazard: Custom sheath Introducer contains incorrect needle size
April 19, 2023Medical DevicesFDA
Merit Medical Systems, Inc. recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Hazard: Product that was built for design verification testing was inadvertently distributed to customers.
November 2, 2022Medical DevicesFDA
Merit Medical Systems, Inc. recalls CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA
Hazard: 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.
November 2, 2022Medical DevicesFDA
Merit Medical Systems, Inc. recalls CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/
Hazard: 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.
April 20, 2022Medical DevicesFDA
Merit Medical Systems, Inc. recalls AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B
Hazard: 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.